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At this year’s American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) Congress, new data on multiple myeloma highlighted several important themes, including the ongoing evolution of myeloma care toward earlier intervention, deeper and more durable responses, increasingly individualized treatment sequencing, and broader implementation of novel immune-based therapies.

For myeloma experts and community oncologists, these are the top takeaways:

Read more below.

New data on treatment for high-risk smoldering myeloma

High-risk smoldering myeloma has emerged as an important setting for evaluating early treatment. A recent study investigated whether immune-based therapies can induce deep responses and prolong progression-free survival (PFS) before the onset of symptomatic disease.

ERASMM examined a fixed two-year course of single-agent elranatamab (elra), a BCMA×CD3 bispecific antibody, in adult high-risk smoldering myeloma patients. This strategy leveraged a less-exhausted immune system earlier in the disease course to achieve deep remissions (overall response rate [ORR] of 92 percent) and nine-month PFS of 95 percent.

These preliminary findings suggest that elra monotherapy may represent an important step toward time-limited treatment in the precursor phase of myeloma, with deep responses, manageable toxicity, and no early signal of excess mortality. Although follow-up remains limited, the study provides early proof of concept for fixed-duration bispecific antibody therapy in high-risk smoldering myeloma.

Longer follow-up will be necessary to determine whether these deep responses translate into durable delays in progression.

Resources for patients: The MMRF’s Myeloma Matters podcast on smoldering myeloma and information sheet on precursor conditions can help patients better understand high-risk smoldering myeloma and help clinicians navigate conversations about monitoring and potential treatment options.

Novel therapies challenge traditional sequencing in early relapsed patients

The treatment landscape for myeloma patients at first relapse is rapidly evolving. New data suggest that highly active immune-based therapies and next-generation cereblon-targeting agents are moving earlier in the treatment continuum and may reshape traditional sequencing strategies.

Results of the landmark phase 3 MajesTEC-9 trial showed that teclistamab monotherapy significantly outperformed investigator’s choice standard regimens—pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd)—in patients with relapsed/refractory myeloma after one to three prior lines of therapy.

The study included patients refractory to both lenalidomide and anti-CD38 therapies. Teclistamab significantly improved survival outcomes and produced markedly higher complete response (CR) rates than standard therapy (median PFS not reached vs 8.2 months; ≥CR 65.9 percent vs 16.8 percent), albeit with increased infection risk (65.9 percent vs 16.8 percent).

These findings demonstrate that single-agent teclistamab remains highly effective in patients with both lenalidomide- and anti-CD38-refractory disease, a population that is increasing with the widespread adoption of daratumumab-based frontline regimens. These data raise further questions about optimal sequencing of bispecific antibodies, CAR-T therapy, and other BCMA-directed approaches.

The phase 3 SUCCESSOR-2 trial addressed another increasingly common clinical challenge: patients whose disease progresses despite prior exposure to both lenalidomide and anti-CD38 therapy.

In this patient population, adding the potent CELMoD mezigdomide (mezi) to carfilzomib–dexamethasone (Kd) significantly improved outcomes compared with Kd alone. Clinically meaningful improvements were observed in PFS (18.0 vs 8.3 months) and ORR (80.2 percent vs 53.4 percent). Benefits were consistent across high-risk subgroups, including older patients, those with high-risk cytogenetics, and patients with extramedullary disease. Mezi-Kd nearly doubled PFS compared with a standard proteasome inhibitor–based regimen, supporting its potential role as a second-line option for lenalidomide-refractory disease.

These findings reinforce the potential of next-generation cereblon modulators to overcome resistance to earlier immunomodulatory drug–based therapy while offering the practical advantages of an oral treatment approach.

These studies suggest that BCMA-directed bispecific antibodies and CELMoDs are moving earlier in the treatment continuum, expanding options for patients with early RRMM and prompting new questions about optimal sequencing.

Resource for HCPs: This MMRF Myeloma Matters podcast offers practical perspectives on the evolving use of bispecific antibodies in clinical practice.

Resource for patients: The MMRF’s information sheet on bispecific antibody therapy explains what this treatment is and how it works.

Rethinking myeloma treatment duration

As myeloma treatment outcomes improve, investigators are increasingly exploring whether therapy duration can be individualized based on depth of response instead of continued indefinitely.

Recent studies explored two emerging strategies: fixed-duration approaches intended to reduce the cumulative toxicities of novel therapies and response-adapted approaches that use sustained deep responses, including minimal residual disease (MRD) negativity, to inform treatment discontinuation.

In the frontline setting, the IDEAL trial evaluated fixed-duration CELMoD-based treatment using iberdomide, daratumumab, bortezomib, and dexamethasone (iber-DVd) followed by iberdomide maintenance. The regimen induced deep responses over time (100 percent ORR and 48 percent MRD negativity), with 88 percent of patients achieving 18-month PFS.

Although follow-up remains relatively short, these findings provide early evidence that fixed-duration response-intensive approaches may be feasible in newly diagnosed myeloma while establishing proof of concept for CELMoD-based frontline therapy.

Complementing these frontline findings, the results of a single-institution retrospective cohort study analysis of patients with relapsed/refractory myeloma who discontinued teclistamab or talquetamab after achieving deep responses suggest that some patients may be able to maintain durable disease control without ongoing bispecific antibody therapy.

However, patients who discontinued treatment generally had more favorable baseline disease characteristics, limiting conclusions regarding the impact of treatment cessation itself. Despite these limitations, the study provides an important early signal that fixed- or finite-duration bispecific antibody therapy may be feasible in carefully selected patients and supports prospective evaluation of response-guided treatment-discontinuation strategies.

Rethinking post-BCMA relapse: sequencing, target switching, and emerging immune strategies

As the use of BCMA-directed therapies expands earlier in the treatment course, optimizing outcomes after BCMA exposure has become a key clinical challenge in relapsed/refractory myeloma. Emerging data highlight ongoing activity of novel agents in the post-BCMA setting while also raising important questions regarding sequencing, immune fitness, and target selection.

A phase 1b analysis of etentamig, a next-generation BCMA-targeted bispecific antibody, demonstrated clinically meaningful activity in heavily pretreated BCMA-exposed relapsed/refractory myeloma, including patients previously treated with CAR T or antibody-drug conjugates (ORR 47 percent; median duration of response ~13 months), with a manageable safety profile despite the absence of step-up dosing. Notably, outcomes were strongest in patients with prior CAR T exposure and recent BCMA therapy. CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were reported in 57 percent and seven percent of patients, respectively, suggesting an improved immune-related adverse event profile.

These data challenge the idea of universal BCMA resistance after prior exposure. The higher ORR and longer PFS in prior CAR T patients suggest that etentamig may be a plausible post–CAR T relapse option, a setting in which treatment choices are often limited and outcomes poor.

Real-world evidence from a retrospective study suggests that treatment sequence—not just agent selection—materially influences outcomes in relapsed/refractory myeloma.

Patients who received CAR T-cell therapy before a bispecific antibody (teclistamab, talquetamab, or elranatamab) had longer overall survival than did those who received a bispecific antibody first (5-year survival 57.1 percent vs 25.5 percent; median overall survival not reached vs 3.6 years). These findings were consistent regardless of whether the bispecific antibody targeted BCMA or GPRC5D.

The safety profile differed by sequence: CAR T first was associated with higher ICANS after first therapy (22 percent vs 10.7 percent); bispecific antibody first was associated with higher ICU admissions and more CRS after second therapy, but infection, sepsis, and one-year mortality were similar.

These findings imply that earlier CAR T use may confer a survival advantage, supporting a shift toward using CAR T before bispecific antibodies when feasible. However, differences in baseline patient characteristics and treatment selection between the cohorts may have contributed to the observed outcomes. These findings highlight the potential importance of treatment sequencing and suggest that the order in which CAR T-cell therapies and bispecific antibodies are used may influence both efficacy and safety outcomes. Randomized studies will be needed to confirm these observations and define optimal sequencing strategies.

Resources for patients: The MMRF’s information sheets on bispecific antibody and CAR T therapies can help patients understand how these treatments work and how they are used.

Expanding options beyond BCMA

As BCMA-directed therapies become more widely used, alternative targets are emerging for patients who relapse after treatment with a BCMA-targeting agent. In patients with relapsed/refractory myeloma treated after one to three prior lines of therapy, the GPRC5D-directed CAR T-cell therapy arlocabtagene autoleucel (arlo-cel) demonstrated high efficacy, with an ORR of 96 percent, CR rate of 67 percent, and 12-month PFS of 74 percent. Responses were durable, and severe CRS or ICANS were not observed, though GPRC5D-related nail, skin, and oral toxicities were common.

In a separate pooled analysis, the FcRH5-targeting bispecific antibody cevostamab demonstrated meaningful activity in heavily pretreated patients previously exposed to BCMA-directed CAR T, achieving an ORR of 43.9 percent and a median duration of response of 17.4 months despite high-risk disease characteristics. These findings demonstrate that effective immune redirection remains possible beyond BCMA and support the growing role of alternative targets such as GPRC5D and FcRH5 in the management of post-BCMA relapse.

Expanding bispecific antibody therapy

As bispecific antibodies become increasingly integrated into the treatment of relapsed/refractory myeloma, attention is shifting toward strategies that can improve safety, reduce treatment complexity, and enable broader use beyond specialized centers. New data highlight emerging approaches to mitigating toxicity and addressing implementation challenges in community oncology settings.

Key findings included:

These findings emphasize that expanding bispecific antibody use will require corresponding toxicity management and supportive care. Improvements in toxicity management, supportive care, and operational readiness may help make these highly active therapies more accessible across diverse treatment settings. As bispecific antibody use continues to grow, practical implementation strategies will be increasingly important.

Resource for HCPs: This MMRF Myeloma Matters podcast highlights practical considerations using bispecific antibodies in clinical practice.

Resource for patients: The MMRF offers an information sheet on bispecific antibody therapy that explains how these treatments work and what patients can expect during treatment, including common side effects and safety monitoring.

Jointly provided by the MMRF and RedMedEd.

This content is supported by sponsorships from Legend Biotech USA Inc. and Pfizer Inc., as well as an educational grant from Johnson & Johnson.

The U.S. Food and Drug Administration (FDA) approved a new combination treatment using Tecvayli® (teclistamab) and Darzalex® (daratumumab), often called Tec-Dara, for people with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 

This approval marks another step forward in expanding treatment options for patients whose myeloma has returned or stopped responding to previous treatments. 

Why This Approval Matters 

Until now, bispecific antibody treatments like Tecvayli have typically been used later in the course of myeloma, often for patients whose disease has returned after four or more prior lines of therapy. 

Darzalex, a monoclonal antibody therapy, is commonly used earlier in treatment, including as part of initial therapy or early relapse regimens. 

The newly approved Tec-Dara combination brings these two approaches together, allowing patients to receive a bispecific immunotherapy much earlier in their treatment journey after just one prior line of therapy. 

For many patients at this stage of relapse, CAR T-cell therapy has been one of the main treatment options. While CAR T can be highly effective, it is usually available only at specialized academic medical centers and may require travel, wait times, and complex coordination of care. 

Because Tec-Dara can be administered in many community oncology practices, this approval may help make advanced immune-based therapies more accessible to patients who may not have easy access to CAR T treatment centers. 

What the Clinical Trial Showed

The FDA approval was based on results from a Phase 3 clinical study that included more than 500 patients with relapsed or refractory multiple myeloma who had previously received one to three lines of treatment. 

Participants received either: 

Patients receiving the Tec-Dara combination experienced significantly longer progression-free survival compared with those receiving standard therapy: 

Side effects were generally manageable and similar between treatment groups, although infections occurred more often in patients receiving Tec-Dara. Patients also experienced cytokine release syndrome (CRS), an immune reaction that is typically mild and treatable with careful monitoring. 

These findings highlight the potential of combining immune-based therapies to produce deep and durable responses for patients whose myeloma has returned. 

Next Steps for Patients

If you or a loved one is living with multiple myeloma and have experienced relapse, talk with your care team about whether this newly approved combination therapy could be an option for you. 

Questions you may want to ask include: 

Your healthcare team can help determine whether Tec-Dara may fit into your treatment plan and discuss how it compares with other available options. 

In addition to your care team, the MMRF Patient Navigation Center can offer support in answering these questions and give one‑on‑one guidance tailored for you. The MMRF Education Hub also offers additional materials to help better understand treatment options and navigate you along your myeloma journey. 

Multiple myeloma (MM) management is evolving toward highly active, immune‑based, and targeted regimens that aim to deepen and prolong responses from first-line through relapsed/refractory (RRMM) settings.

Several presentations at the 2025 American Society of Hematology Annual Meeting in Orlando introduced new and updated study data on the management of MM, along with potentially significant advancements in therapy. Topics included strategies for deepening treatment responses in pts with newly diagnosed MM (NDMM), emerging roles of cereblon E3 ligase modulators (CELMoDs) and bispecific antibody (bsAb) combinations in early RRMM, and the evolving roles of CAR T and trispecifics.

Exploring Strategies to Deepen Responses for NDMM

Across multiple phase 2 and 3 studies, bsAbs and fixed-duration immunoconsolidation strategies show promise in deepening responses—including minimal residual disease (MRD) negativity—when introduced earlier in the treatment course, even in older or transplant-ineligible (TI) pts. Four presentations examined investigational strategies for intensifying therapeutic responses.

Abstracts can be found here, here, and here.

Characterizing infection risk in the phase 3 MagnetisMM-6 trial of elra + dara and len in TI or -deferred NDMM pts

One key consideration of bsAb therapy is infections.

The ongoing MagnetisMM-6 trial is evaluating whether adding the BCMA-targeted bsAb elranatamab (elra) to dara and lenalidomide (len; EDR) can improve outcomes compared with the combination of dara, len, and dexamethasone (dex; DRd) in TI or transplant-deferred NDMM pts—a regimen more commonly used outside the U.S. The recommended phase 3 dose was selected from Part 1 of the study based on the early and promising efficacy and manageable safety profile of EDR in pts with RRMM and TI NDMM and was recently presented.

An additional analysis from Part 1 described the characteristics of infections observed in pts who received EDR. Pts (N=34) received EDR, and infections were reported in 70.3% (G3, 18.9%; no G4). One pt had a G5 AE of Candida pneumonia. The most frequent infections were upper respiratory tract infection (21.6%; G3 0%), pneumonias (16.2%; G3 8.1%), and urinary tract infection (10.8%; G3 2.7%). Most first infections (56.8%) occurred within 8 weeks of starting treatment and tended to decrease over time. Anti-infectious prophylaxis was given to 83.8% (Pneumocystis jirovecii pneumonia), 81.1% (viral), 16.2% (fungal), and 10.8% (bacterial) of pts. The majority (91.9%) received Ig replacement. Neutropenia (G3/4) was reported in 73.0% of pts, 8.1% had febrile neutropenia, and most (73%) received granulocyte colony-stimulating factor. Ultimately, treatment with EDR requires close monitoring and prompt intervention to minimize the risk of infection.

Findings from Part 1 supported selection of EDR for phase 3 evaluation based on early and promising efficacy and a manageable safety profile. For Part 2 of this study, approximately 870 adults will be randomized 1:1 to determine whether EDR can improve depth and durability of disease control compared with DRd, with dual primary end points of MRD negativity at 12 months and progression-free survival (PFS).

Notable Outcomes in Early RRMM

Late-breaking phase 3 data (now published) suggest that combining the BCMA-directed bsAb tec with dara may achieve deeper response depths and durability than previously reported in randomized RRMM trials, highlighting the potential clinical relevance of this combination. Although tec is currently approved for use in heavily pretreated RRMM, its evaluation in earlier LOT remains investigational. However, this study highlights the therapeutic potential of more readily accessible, off-the-shelf immunotherapy–based regimen for patients with early RRMM.

Phase 3 MajesTEC-3 study: tec-dara vs dara + dex + either pom or bortezomib (DPd/DVd) in RRMM

Predicting Responses in CAR T-Cell Therapy

Paired subanalyses from the CARTITUDE-4 study evaluated risk-specific outcomes in patients treated with ciltacabtagene autoleucel (cilta-cel) to better understand predictors of early relapse and long-term disease control. These analyses reinforce the role of cilta-cel as a highly effective option in early relapsed MM while also identifying patient- and disease-related factors that may influence durability of benefit.

Two presentations focused on distinct risk-based subgroups of cilta-cel-treated patients:

Evolving Treatment Approaches in High-Risk Pts

Novel combinations, targeted approaches for molecular subsets, and dual-antigen strategies highlight progress for pts with high-risk features (cytogenetics, extramedullary disease), or limited durability with standard regimen, offering more opportunities to overcome historically poor outcomes.

Talquetamab + tec in pts with RRMM

The phase 1b RedirecTT-1 trial (here and here) investigated the combination of talquetamab (tal, anti-GPRC5D × CD3) and tec (anti-BCMA × CD3) in pts with triple-class-exposed RRMM, including those with true EMD (defined as ≥1 nonradiated plasmacytoma ≥2 cm not contiguous with bone). At a median follow-up of 36.2 months in the recommended phase 2 regimen (tal 0.8 mg/kg + Tec 3.0 mg/kg Q2W), ORR was 79.5% with ≥CR in 61.4% of pts. ORR was 61.1% and 92.3% in pts with or without EMD, respectively. Lower EMD tumor volume correlated with higher ORR (<25 cm2: 90.7%; 25–50 cm2 66.7%; 50 cm2: 65.4%), suggesting prognostic value.

Most common AEs were CRS (80.9% [G3, 2.1%; G4/5, 0%]), neutropenia (74.5% [G3/4, 70.2%]), taste changes (66.0% [all G1/2]), and non-rash skin AEs (62.8% [G3, 2.1%]). Infections occurred in 93.6% of pts (G3/4, 68.1%); the most common was COVID-19 (40.4% [G3/4, 17.0%]). This extended 3-year follow-up confirms that tal + tec provides durable, deep, and potentially survival-prolonging responses with a manageable and predictable safety profile in heavily pretreated RRMM.

Tal + tec demonstrated robust and durable responses in pts with triple-class-exposed RRMM and true EMD, a group with historically poor outcomes. In addition, the safety profile is manageable and in line with known monotherapy toxicities.

Elra + iber in RRMM

In the phase 1b MagnetisMM-30 trial, elra + the oral CELMoD iber showed promising antimyeloma activity and a manageable safety profile in 22 heavily pretreated pts: 4 with EMD; 9 with high-risk cytogenetics defined as t(4;14), t(14;16), or del(17p); 1 with Revised International Staging System stage III; and 2 with ≥50% baseline bone marrow plasma cells. The ORR (unconfirmed) was 90.9%, with nearly half (45.5%) achieving ≥CR. Elra + iber demonstrated strong early efficacy and acceptable tolerability in RRMM, supporting continued evaluation.

Next-Generation Therapies: CAR T

Updated registrational data and first-in-human studies showcase the rapid evolution of CAR T-cell therapy, including next-generation constructs, dual-targeting strategies, and gene-therapy approaches designed to simplify manufacturing while extending responses, even in pts with disease refractory to multiple prior LOT. Extending dual-target CAR T innovation beyond MM, early-phase data explore feasibility and activity in relapsed AL amyloidosis.

Phase 2 iMMagine 1 trial of anito-cel for RRMM: update

Dual-targeting BCMA and CD19 FasTCAR-T (GC012F/AZD0120): platform innovation and clinical applications

GC012F/AZD0120 is an autologous dual-target BCMA/CD19 CAR T therapy manufactured via the FasTCAR-T next-day platform (a manufacturing approach designed to substantially shorten development time, potentially reducing the need for prolonged bridging therapy and allowing earlier intervention). In 30 treated NDMM pts (following 2 cycles of RVd induction therapy), the ORR was 100%, with a 97% sCR. All pts achieved MRD negativity (10-6), and just over 80% maintained MRD negativity beyond 12 months. After a median follow-up of 30 months, neither PFS nor OS had been reached, with 30-month PFS and OS rates of 88% and 92%, respectively. GC012F/AZD0120 was well tolerated, with grade 1–2 CRS in 33% of pts and no neurotoxicity. GC012F/AZD0120 demonstrates exceptional efficacy, durable MRD negativity, and a favorable safety profile, warranting larger confirmatory trials.

The FasTCAR-T platform is now being explored beyond MM in relapsed or refractory (RR) light chain (AL) amyloidosis, a plasma cell (PC) disorder and occurs in 10% to 15% of MM pts. In about one third of pts, second-line therapy is needed within 22 months following first-line dara + CyBorD. Yet there are no approved therapies for relapsed or refractory (RR) AL amyloidosis. New therapies inducing deep and durable responses are needed to extend survival.

ALACRITY, a phase 1b/2 trial, will evaluate the use of AZD0120 in RR AL amyloidosis. Pts enrolled on the study must have relapsed or be refractory to ≥1 prior line of anti-PC-directed therapy, including a CD38 monoclonal antibody and a PI. Pts who have had prior CAR-T or BCMA-directed therapy, or any FDA-approved or investigational T cell engaging therapy (eg, bispecifics/trispecifics) at any target within the last 6 months will be excluded. The recommended phase 2 dose (RP2D) will be selected based on safety, preliminary efficacy, cellular kinetics, and pharmacodynamics. Phase 2 will enroll 79 pts at the RP2D.

MRD-negative outcomes following a novel in vivo gene therapy generating BCMA CAR T cells in RRMM

A late-breaking first-in-human phase 1 study evaluated KLN-1010, an investigational in vivo BCMA-directed CAR T–gene therapy designed to generate CAR T cells without ex vivo manufacturing or lymphodepletion, representing a truly next-generation approach to cellular therapy. In this very small cohort of three heavily pretreated, high-risk patients, treatment was feasible and generally well tolerated, with all patients achieving early MRD-negative responses—findings that warrant cautious interpretation but underscore the potential of in vivo CAR T strategies.

Next-Generation Therapies: Bispecifics and Trispecifics

Emerging bispecific and trispecific platforms demonstrate improved convenience, manageable safety, and expanding clinical versatility, including post-CAR T consolidation and novel multitarget engagement that may further extend the reach of T-cell redirection strategies.

Kilimanjaro: a phase 1b dose-escalation and safety expansion study of etentamig + pom + dex in RRMM

Etentamig (a BCMA × CD3 bsAb with unique design features that can reduce CRS, extend half-life, and offer a convenient monthly dosing schedule) was evaluated in combination with pomalidomide (pom) + dex in 85 RRMM pts. Pts had a median of 4 prior LOT; 73% were triple-class refractory; 58% were exposed to pom (half were pom-refractory). ORR in evaluable pts was 81% (72% ≥VGPR). The most common G3/4 hematologic AEs were neutropenia (788%), anemia (28%), and thrombocytopenia (22%). CRS occurred in 37% of pts (G1, 25%; G2, 12%; G≥3, 0%). ICANS was reported in 7% of pts (most G1/2; 1 pt with G3). Infections (G3/4) occurred in 49% (most common, pneumonia). Etentamig regimens will be explored in a randomized phase 3 study based on these results.

Non–BCMA-targeted bsAbs in RRMM

Early-phase studies of non-BCMA T-cell–redirecting therapies highlight the growing role of alternative targets in RRMM. Cevostamab, a CD3 × FcRH5 bsAb, demonstrated manageable safety—primarily low-grade CRS and hematologic toxicities—and meaningful activity both as post–BCMA CAR T consolidation (with high rates of MRD negativity) and as a subcutaneous regimen in heavily pretreated patients, achieving ORRs of approximately 40%. In parallel, the first-in-human trispecific antibody IBI3003 targeting GPRC5D, BCMA, and CD3 showed promising early efficacy with ORRs ranging from 50% to 100% across dose levels, including in patients with prior BCMA or GPRC5D exposure and extramedullary disease, with toxicity that was generally manageable.

 

Jointly provided by the MMRF and RedMedEd.

Support for this activity has been provided through sponsorships from Alexion Pharmaceuticals, Inc.; Legend Biotech USA Inc.; Pfizer Inc.; and Sanofi and by educational grants from AbbVie Inc. and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, Affairs, LLC.

Over three days, the 2025 International Myeloma Society (IMS) Annual Meeting featured dozens of new and updated clinical trial results, illustrating significant advancements in therapy from newly diagnosed (NDMM) to relapsed/refractory multiple myeloma (RRMM).  

Topics included real-world CAR T insights, evolving outpatient (OP) and modified bispecific antibody (bsAb) practices, expanding roles for bsAbs in NDMM and smoldering MM (SMM), tailored approaches for high-risk disease, new analyses of quadruplets, growing evidence for cereblon E3 ligase modulatory drugs (CELMoDs) across treatment settings, emerging experimental agents that highlight the importance of clinical trial participation, and a broad set of new biomarkers that refine risk assessment and treatment response prediction. 

Real-World Insights Reveal CAR T Benefits and Tradeoffs 

Real-world evidence comparing ide-cel and cilta-cel underscored the durable responses and varying toxicity profiles of each CAR T therapy, offering important comparative insights in the absence of head-to-head clinical trials. 

Real-world comparison of ide-cel and cilta-cel via CIBMTR data

Transforming bsAb Care: OP SUD and Other Practices

Multiple real-world studies confirmed that OP or hybrid step-up dosing (SUD) of bsAbs such as teclistamab (tec) and talquetamab (tal) is both safe and practical, especially with prophylactic dexamethasone (dex).  

Limited-duration therapy and reduced-frequency regimens, such as less-frequent elranatamab dosing, demonstrated that individualized schedules can maintain efficacy. Notably, a new analysis comparing prophylactic dex + OP SUD vs standard inpatient (IP) observation examined the potential to reduce financial toxicity and resource burden. These results highlight how community practices can deliver advanced therapies while maintaining convenience, safety, and lower costs. 

Retrospective cohort study of limited-duration bsAb therapy

Factors independently predicting inferior RFS included: 

The most common causes of treatment discontinuation included infections (44% of pts) and ectodermal toxicities (15%). Post-discontinuation risk: 

Phase 2 MagnetisMM-3 trial of elranatamab less-frequent dosing in RRMM

Outcomes of OP SUD of tec and tal

ICANS emerged within 14 days as follows: OP 4% (G2), IP 6% (various grades), HY 13% (mostly G1) 

Prophylactic dex with OP SUD of bsAbs vs standard-of-care (SOC) IP observation

OP monitoring was safe, with no severe ICANS beyond G1 detected, and CRS events were managed effectively with OP interventions for G1. Tocilizumab use was significantly lower in the OP group (12.5% vs 42%; P=0.03), correlating with fewer severe CRS events.  

 bsAbs Expand Options for NDMM and SMM

New findings highlight how bsAbs are advancing into earlier LOT. The first results from the phase 2 LINKER-SMM1 trial show that linvoseltamab may also offer clinical benefit for pts with high-risk SMM, suggesting a potential role for bsAbs in delaying disease progression and redefining early intervention strategies.  

Additionally, phase 2 and early phase 3 data suggests that bsAbs like teclistamab and elranatamab, combined with standard agents, may be feasible and effective in NDMM pts. These findings point to a future where bsAbs may be given earlier in treatment—at least for a subset of pts; phase 3 trials are now under way. 

Phase 2 Linker-SMM1 study of linvoseltamab for high-risk SMM

Phase 2 GMMG-HD10/DSMM-XX (MajesTEC-5) of tec

Steroid use was limited to early induction cycles. 

Phase 3 MagnetisMM-6: part 1 of elranatamab + lenalidomide ± daratumumab

Tailored Strategies Improve Outcomes in High-Risk MM

New data explored optimized approaches for pts with high-risk or refractory features, including dual-bsAb combinations in EMD via the RedirecTT-1 study, the largest EMD study to date. This study reinforces the value of tailoring therapy intensity and combination strategy to disease biology. 

Phase 2 RedirecTT-1 trial of tal + tec for EMD

Updated Trial Analyses Provide Insights Into Quadruplets for NDMM

Updated analyses were presented from key NDMM trials such as PERSEUS, CEPHEUS, IMROZ, and the phase 2 ISASOCUT study (subcutaneous [SC] isatuximab [isa] combined with bortezomib, lenalidomide, and dex). These analyses highlight pt-reported outcomes and safety findings, offering insights into regimen tolerability and response trends. These results show how pts fare in real-world and clinical trial settings and inform considerations for dosing schedules and management strategies. 

PROs and safety from the phase 3 PERSEUS and CEPHEUS trials

Model-based assessment of monthly isa dosing

Phase 2 ISASOCUT (IFM 2022–05) study of SC isa + bortezomib + lenalidomide + dex in NDMM

CELMoD Therapies Expand Options Across Treatment Lines

CELMoDs, a class of next-generation immunomodulatory agents, are designed to enhance tumor cell degradation while stimulating the immune response. Agents such as iberdomide and mezigdomide demonstrated activity across multiple LOT, including in pts previously exposed to standard immunomodulatory imide drugs. These therapies offer potential accessibility for a broad range of pts due to manageable safety profiles and oral administration. 

Phase 1/2 CC-220-MM-001 trial of iberdomide-daratumumab-dex in TI/deferred NDMM

Mezigdomide in novel combinations

Experimental Therapies Highlight Need for Clinical Trial Consideration

First-in-human and phase 1/2 data showcased innovative therapeutics. These included a novel trispecific antibody and CAR T constructs to other novel agents, including the antibody-drug conjugate (ADC) HDP-101, the BCL-2 inhibitor sonrotoclax, and dual-target CAR Ts.  

These agents demonstrated encouraging efficacy and safety profiles that support continued clinical development. Importantly, the data highlights emerging questions about how best to combine or sequence these potent therapies.  

Many of these trials enrolled pts who were heavily pretreated and refractory to multiple standard therapies. Efficacy in this difficult-to-treat population appears encouraging, underscoring the importance of clinical trial participation. Until optimal sequencing and combination strategies are defined, clinical trial participation remains essential. 

Phase 1/2a trial of HDP-101

Sonrotoclax + dex in pts with t(11;14)-positive RRMM

Phase 1 TRIgnite-1 Study of ISB 2001

Phase 1 study of arlocabtagene autoleucel

Phase 1 trial of arlo-cel in pts with 1–3 prior regimens

Phase 1 TANDEMM trial of concurrent administration of BCMA and GPRC5D CAR T cells

New Biomarkers for Risk and Response

Emerging data highlighted new biomarkers that improve risk assessment and predict treatment outcomes, including MRD tracking via circulating tumor DNA. These findings potentially shift MM closer to an individualized treatment approach guided by immune and genomic profiling.  

Two additional studies validated genomic-based models that better classify high-risk MM. The consensus model and new IMS/IMWG criteria aim to unify how high-risk disease is identified, improving trial design and individualized treatment strategies. 

ClonoSEQ MRD testing from BM and circulating tumor DNA

CTCs as a critical biomarker

Higher CTC levels consistently predicted inferior PFS (HR 1.17, 95% CI 1.11–1.24, P<0.001), and the prognostic value remained consistent across subgroups, independent of R-ISS, 1q gain/amplification, induction regimen, or transplant status. In addition, CTC cutoffs between 0.01% and 0.1% reliably stratified pts in both trial and real-world settings and stratified pts with established risk factors: standard-risk pts with high CTCs had outcomes similar to those with high-risk cytogenetics but low CTCs (42 vs 36 months, P=0.48). 

High-risk genomic consensus model validation

IMS/IMWG risk-assessment criteria

Findings remained significant in multivariate analysis, confirming the independent prognostic utility of the criteria. Subgroup analyses demonstrated consistently inferior OS for high-risk vs standard-risk pts across age (>65, no high-dose melphalan with ASCT), performance status (ECOG ≥2), and treatment intensity (including quadruplets). 

 

Jointly provided by the MMRF and RedMedEd. 

Support for this activity has been provided through sponsorships from Legend Biotech USA Inc., Pfizer Inc., and Sanofi and by educational grants from AbbVie Inc. and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC.  

For the last day of ASH, we’re taking a final look at some of the most exciting findings shared during Sunday’s sessions as well as late-breaking abstracts from this morning that highlight where myeloma research is headed next. Whether by investigating new regimens with already-approved treatments, or by developing unique, novel immunotherapies, the studies featured in our post today offer encouraging options for patients who need effective therapy options after relapsing.  

Read the MMRF’s key takeaways below, and catch up on day one and day two.

For a deeper dive into the most important findings from ASH, join us for our Conference Highlights Webinar on December 17. Register here.

Combining the BCMA-targeting bispecific antibody Tecvayli (teclistimab) with Darzalex (daratumumab) leads to lasting responses for relapsed/refractory patients

In a phase 3 study, more than 500 patients who had relapsed after 1-3 prior therapies were given either one of these treatments:  

Patients taking the TD combination had a significant improvement in surviving without their disease progressing, compared to those who had either triplet therapy (83% vs. 29%). Disease did not progress in the TD group of patients for up to 3 years.  

Side effects were mostly comparable between groups, with infections slightly occurring more in patients who were taking TD. Patients taking TD also experienced cytokine release syndrome that was mild mainly treatable. 

Taken together, results from this late breaking abstract demonstrate that the combination of Tecvayli and Dazalex has the potential to be a new standard of care for patients who relapse early, especially on immunodmodulatory drugs like Revlimid or proteasome inhibitors like Velcade or Kyprolis.

New targets for bispecific and trispecific antibodies offer a path forward for relapsed/refractory patients with limited treatment options

Cevostamab: We heard new data on the bispecific antibody cevostamab as a treatment for relapsed/refractory myeloma, including patients with high-risk disease features and patients who have already received multiple other lines of therapies. Cevostamab targets a protein on myeloma cells called FCHR5—a different protein than the BCMA target used in Tecvayli, Lynozyfic,® and Elrexfio or the GPRC5D target used in Talvey (talquetamab). Therefore, it may help patients whose disease is resistant to those treatments. It is also given as an injection, rather than by IV, which provides greater convenience.

IBI3003: IBI3003 is a new trispecific antibody that targets BCMA, GPRC5D, and CD3—combining the activity of two bispecifics in one drug. In a Phase 1 study of 28 patients who had received at least two prior treatments, all patients given the highest doses responded, including those with high-risk disease and those previously treated with BCMA or GPRC5D therapies like Tecvayli or Talvey. The most common side effects were fever and flu-like symptoms, and serious side effects were uncommon.

In patients who have exhausted treatment options targeting BCMA or GPRC5D with currently approved bispecifics or CAR T-cell therapy, these studies show that targeting other molecules on myeloma cells can offer therapeutic benefit. 

Bispecific antibody combination show promises for relapsed/refractory patients with high-risk disease

High-risk multiple myeloma is a more aggressive form of the disease, often characterized by certain genetic changes, high levels of specific blood markers, or myeloma growing outside the bone marrow (extramedullary disease or EMD). These features can make the cancer harder to treat and more likely to return sooner, so patients may need stronger or more tailored treatment approaches. A combination of two bispecific antibodies — Talvey and Tecvayli — is showing particular promise for these patients. 

Here’s a recap of the data:

Despite these safety risks, this combination remains one of the most effective treatments reported for patients with this aggressive form of myeloma who otherwise have limited treatment options. It’s important to review the potential benefits and risks with your care team when considering this approach.

What’s Down the Road: In-vivo CAR T-Cell Therapy 

Finally, in today’s late-breaking session, a phase 1 study explored the possibility of in-vivo CAR T therapy in a small group of 3 patients. Unlike traditional CAR T-cell treatment, which involves the removal of T-cells from patients and genetically reprogramming them in a lab, in-vivo CAR T can be accomplished inside the body, without the need for these steps or even bridging therapy. Simply put, a special infusion is given to patients that lets their own immune system generate CAR T-cells against BCMA.  

In the study, patients experienced low-grade cytokine release syndrome which was treatable. Within one month, each of them so far has no detectable disease in the bone marrow.  

While this study is early and involves only a small number of patients, it highlights the transformative potential of in-vivo CAR T therapy to simplify and broaden access to this powerful treatment approach. Notably, within the MMRF’s Myeloma Investment Fund portfolio, we have two in-vivo CAR T programs in development, an exciting step because eliminating the need for complex cell collection and manufacturing could make CAR T therapy more accessible to a much wider patient population. 

 

That wraps up our coverage from ASH 2025. Be sure to stay connected with the MMRF for updates as these findings continue to move from clinical trials toward everyday care. 

Today’s update from the 2025 ASH Annual Meeting highlights new and existing therapies that could improve care for patients at all stages of multiple myeloma. Read the key takeaways below, and be sure to catch up on the first day.

For a deeper dive into the most important findings from ASH, join us for our Conference Highlights Webinar on December 17. Register here.

For day 2, ASH presentations focused on existing therapies and asked two very important questions: 1) how well do they work, and 2) what can be done to improve them?

Answering this first question, new data covering the effectiveness of Isa-VRd (Sarclisa, Velcade, Revlimid, and dexamethasone) in different patient populations was presented, as well as updated data on Carvytki (cilta-cel), a CAR T-cell therapy that shows strong potential for providing long-lasting disease control for patients whose myeloma has relapsed.

To answer the second question, researchers presented on CELMoDs, a new class of oral therapies designed to enhance the immune response in myeloma. Studies showed encouraging results when CELMoDs were paired with different treatments across various stages of the disease.

New data support the use of Isa-VRd as a standard of care in newly diagnosed patients, with potential impact on quality of life

New data from a Phase 3 study suggest that Isa-VRd is more effective than Isa-Rd in treating older, high-risk NDMM patients who cannot undergo a stem cell transplant. As a reminder, Sarclisa is a monospecific antibody, similar to Darzalex.®

The study included over 200 patients aged 65–79 with high-risk disease features, such as certain genetic changes or high levels of a blood protein called β2-macroglobulin. Results showed:

Another study highlighted the impact of Isa-VRd treatment on quality of life. In over 600 newly diagnosed patients who were eligible for a stem cell transplant, Isa-VRd was linked to pain reduction, improved fatigue, and overall favorable quality of life compared to VRd alone.

IsaVRd is currently FDA-approved in the U.S. for NDMM patients not eligible for a stem cell transplant. However, some patients may access IsaVRd off-label, meaning it is used in ways not specifically approved by the FDA, based on a doctor’s judgment. Talk to your care team to see if IsaVRd may be an appropriate option for you.

Carvykti® keeps multiple myeloma under control for longer than standard 3-drug therapy

A large, Phase 3 study concluded that a single infusion with the CAR T-cell therapy Carvykti helped keep multiple myeloma under control longer than a standard 3 drug therapy, offering promise as an earlier treatment option for patients with relapsed/refractory myeloma. In this study, Carvykti was compared to two standard regimens: PVd (Pomalyst®, Velcade®, and dexamethasone) or DPd (Darzalex®, Pomalyst®, dexamethasone). Even after 2.5 years, three out of four patients treated with Carvykti still had their disease under control, compared to less than half of those treated with standard therapies. No new side effects were reported.

These data suggest Carvykti can provide safe and lasting disease control when used earlier in patients who have relapsed.

Can CELMoDS enhance immunotherapy in early disease and late relapse?

CELMoDs, which include the drugs iberdomide and mezigdomide, are oral treatments designed to help the immune system target and attack myeloma cells. CELMoDs work in a similar way as immunomodulatory agents, such as Revlimid® or Pomalyst®, but are designed to be more potent and effective. Oral treatments offer additional benefits in that they are easy to take and are available to anyone regardless of where they live.

One essential quality of CELMoDs is their ability to “rev up” the immune response. At ASH, many studies were focused on how well CELMoDs can enhance existing therapies. Whether combined with early-line therapies like stem cell therapy (ASCT) or later-line therapies like Elrexfio (elranatamab, a bispecific antibody), researchers are exploring whether CELMoDs can be effective across different stages of the disease—helping to deepen responses, achieve no detectable disease, and provide options for long-term treatment.

While CELMoDs are not yet available for routine clinical use, researchers are actively working to better understand their safety and effectiveness for potential future approval.

Stay tuned for tomorrow’s final dispatch from ASH 2025, where we’ll bring you even more exciting updates on groundbreaking research that is shaping the future of multiple myeloma care.

The 67th ASH Annual Meeting is underway in Orlando, where more than 30,000 experts have gathered to share the newest research in multiple myeloma and other blood cancers. The MMRF team is here on the ground, connecting with leaders in the field and bringing you updates as they happen.

Over the next three days, we’ll highlight promising new research and key insights shaping the future of myeloma treatment, many of which align with MMRF’s strategic research priorities and address critical unmet patient needs.

On Day 1 of ASH, studies focused on addressing the unmet needs of high-risk patients as well as finding ways to improve existing standards of care for all patients along their journey.

To dive deeper into these findings and additional updates from ASH, read more below and join us for our Conference Highlights Webinar on December 17. Register here to hear from leading experts and stay informed on the latest advancements.

As a reminder, many of the studies being presented, particularly oral abstracts, are early in nature. While the results shared at ASH can be very strong and encouraging, much larger trials will need to be completed to confirm these initial findings, especially in patient populations that are representative of the real-world patient population in the U.S.

New CAR T Treatment Tested in High-Risk, Newly Diagnosed Patients

High-risk multiple myeloma is a more aggressive form of the disease, often marked by certain genetic changes, high levels of specific blood markers, or myeloma growing outside the bone marrow. A real-world study presented today reinforced that these high-risk features can make myeloma harder to treat and more likely to return sooner, highlighting the need for closer follow-up or additional therapy for these patients.

A small, phase 1 study presented early data on a potential new treatment for high-risk newly diagnosed patients who are not eligible for a stem cell transplant. Sixteen patients received an infusion of the CAR T-cell therapy eque-cel. All had a deep response within the first month, including complete responses and minimal residual disease (MRD) negativity, meaning no detectable myeloma using very sensitive tests. Most patients stayed MRD-negative for two years, keeping disease under control during this follow-up period.

Common side effects included CRS (cytokine release syndrome), low blood counts, and infections, but no cases of ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) or other neurological toxicity were reported. While these results are promising, more patients and longer follow-up time are needed to confirm the benefits of eque-cel as an early treatment option for this high-risk group.

Improving Treatment Strategies for Newly Diagnosed Patients

New research shows real progress in treating people who are newly diagnosed with multiple myeloma. Three studies presented today look at different treatment approaches, including updated drug combinations, a CAR T-cell therapy that can be made in one day instead of weeks, and an immune-based treatment typically used for treating patients with relapsed/refractory disease.

Response Measure KRd VRd
Overall Response Rate (ORR) 94% 91%
Complete Response (CR) 71% 53%
MRD-Negative 31% 18%

Side effects were similar between the two treatments: serious side effects occurred in about 7 in 10 patients on KRd and 6 in 10 on VRd, the most common of which were low white blood cell counts and infections. Patients treated with KRd had fewer nerve-related problems than VRd, but slightly more heart-related effects, while patients treated with VRd had more neuropathy than patients treated with KRd.

New CAR T-cell therapy shows promise in treating relapsed/refractory patients with limited options

A Phase 2 study tested anito-cel, a CAR T-cell therapy designed to more easily attach to myeloma cells using a small “hook”—a feature that may help reduce certain side effects seen with other CAR T-cell therapies. Key findings from 117 patients included:

These data suggest that anito-cel may offer strong, long-lasting control of myeloma, with manageable side effects, even for people whose disease has stopped responding to many other treatments.

We’re hopeful about the progress shared today at ASH—and we’ll be back tomorrow with more updates for the myeloma community.

People living with multiple myeloma often relapse after several lines of therapy. When this happens, it can feel like options are running out. The recent approval of Lynozyfic (linvoseltamab-gcpt) is an important step forward in expanding treatment option for patients.

Lynozyfic was approved in July 2025 for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.[1] Here are some important details about Lynozyfic:

A clinical trial with myeloma patients who had received at least four prior treatments showed that 70% of them responded to Lynozyfic treatment. Of these individuals:

Lynozific (linvoseltamab-gcpt) Trial Results Graphic 1

[1] Including a proteasome inhibitor (such as Velcade, Kyprolis, or Ninlaro), an immunomodulatory agent (such as Revlimid or Pomalyst), and an anti-CD38 monoclonal antibody (such as Darzalex or Sarclisa).

Lynozyfic is given through an intravenous infusion:

Like many myeloma treatments, Lynozyfic can cause side effects. The most common is cytokine release syndrome, which can cause fever, chills, or trouble breathing. If these signs occur, it’s important to report them to your care team right away.

Several options are available for avoiding or reducing side effects. Neurologic problems—in particular, immune effector cell-associated neurotoxicity syndrome (ICANS)—can also occur, but they are not as common as CRS.

Side effects and Symptoms - Lynozific

Because of the side effect risks, Lynozyfic is only available through a special safety program. If you receive Lynozyfic, you’ll be given a wallet card to remind you and your care providers of what to watch for.

If you’re a caregiver for a myeloma patient, make sure the patient carries their wallet card and watch the patient for symptoms. If any develop, report them to the care team right away.

As with any myeloma treatment, it’s important for you and your caregiver to have open conversations with your care team about whether Lynozyfic is a good fit. If you’ve already been through several treatments, Lynozyfic offers a new chance at controlling your myeloma.

Interested in learning more about Lynozyfic? Talk to an MMRF patient navigator at the Patient Navigation Center at 1.888.841.MMRF (Monday through Friday, 9:00 AM to 7:00 PM ET) or email [email protected].

Additional Resources

A year after enrolling its first patient, the Horizon One clinical trial already has important wins to celebrate: Not only is it pioneering important research for patients with relapsed and refractory multiple myeloma, but it’s enrolling a patient population that’s far more representative of the disease than other trials to date.

The Horizon Clinical Trials program, which is run by the MMRF’s Multiple Myeloma Research Consortium® (MMRC®), is innovative by design, starting with the fact that it’s aiming to optimize treatments for patients with significant unmet need. Horizon One is enrolling patients with relapsed and refractory multiple myeloma, while the forthcoming Horizon Two trial will enroll high-risk, newly diagnosed patients.

Unlike a traditional clinical trial, Horizon is what’s known as an adaptive platform clinical trial. This unique design allows investigators to test several treatments at the same time and has built-in flexibility to add or remove therapies in real time—all with the goal of generating data and insights at an accelerated pace.

Speed is especially important for the patients in Horizon One. While there are currently more than 15 FDA-approved drugs for the disease, the devastating reality is that most patients will relapse when the disease becomes resistant to a therapy. Others may eventually become refractory (unresponsive) to many kinds of treatment.

“This patient population needs more options, and they need them fast,” said the MMRF’s Chief Medical Officer Hearn Jay Cho, MD, PhD. “These patients and their providers still face complex questions about what treatments will be most effective and in what order. Horizon is designed to answer those critical questions that other types of trials can’t.”

Horizon is innovating in another way: by enrolling a study population that is representative of multiple myeloma patients across the United States. In doing so, the Horizon trial can generate new insights and answer questions that impact all patients.

Historically, clinical trials in multiple myeloma have not been as inclusive.

About 20 percent of multiple myeloma patients in the U.S. are Black, but those patients have been significantly underrepresented in clinical trials. In fact, one analysis of multiple myeloma trials conducted over a 13-year period found that only four percent of enrolled patients were Black.

The average age of a multiple myeloma diagnosis is 69, and two-thirds of people diagnosed with the disease are 65 years or older. But studies have found that these patients are also left out of research. One analysis found that patients over the age of 70 are half as likely to enroll in multiple myeloma clinical trials, and another found that nearly two-thirds of trial participants over a 16-year period were under the age of 65, not at all representative of the disease’s true age demographic.

But the MMRC’s Horizon trial is working to reach the broadest myeloma population—and succeeding.

As of now, more than 25 percent of patients enrolled in Horizon One identify as Black. Seventy-one percent of patients are 71 or older, with more than 20 percent between 81 and 90 years old, percentages that are rarely, if ever, seen in other myeloma trials.

Horizon One is also working to enroll across a mix of geographical locations, including in rural areas and at 25 community hospitals and clinics. In fact, the MMRC Horizon One trial recently opened the first-ever myeloma clinical trial in Flint, Michigan.

Meeting these impressive goals has required considerable collaboration that the MMRC—with its vast network of 13 major medical centers and researchers and a leadership team with decades of expertise and industry connections—is uniquely positioned to facilitate.

Working closely with the MMRC’s Health Equity Advisor Dr. Craig Cole of Karmanos Cancer Institute, the Horizon team has surveyed MMRC sites, collecting data and insights about why patients enroll and, importantly, why they don’t. Dr. Cole and the MMRC team have also brought all 13 MMRC sites together to share learnings and wins.

“Clinical trials have been exclusionary to older people, people of color, and people who live far from academic medical centers. We can enroll those populations by knowing why patients don’t consent to the clinical trial,” Dr. Cole said. “We’re making cultural change. The MMRC sites are sharing stories and ideas and thinking outside the box about how we can improve what we’re doing.”

Many of the trial’s wins, like the launch in Flint, came out of simply having intimate, one-on-one conversations out in the community.

“I did a church basement talk in Flint at an African American church, and I gave my awareness talk about what myeloma is,” Dr. Cole said. “And this little old lady said, ‘You need to bring clinical trials to us. I don’t want to hear about myeloma and all your fancy drugs that you give in Detroit.’ I took it back to the MMRC and said, ‘A little old lady told me to bring a clinical trial to Flint, and I think we really need to do that.’ And the MMRC leadership made that happen. Now, that little old lady can go down the street, get her bispecific, go home, and hang out with her grandchildren.”

Understanding that cures don’t come out of silos, the MMRF and MMRC have a long history of making their learnings and data available to the wider multiple myeloma field. Looking forward, the Horizon trial investigators plan to share their experiences and findings for other researchers, pharma, academic medicine, and others to learn from.

“We’re so proud to conduct trials like Horizon that will help us better understand the disease across a representative population and regardless of where someone lives,” said MMRF’s Senior Vice President of Clinical Research and Regulatory Affairs Katie Wozniak. “That’s how we’ll improve care and find cures for everyone diagnosed with multiple myeloma.”

The MMRF is excited to share that the FDA has approved Blenrep (belantamab mafodotin) combinations for multiple myeloma patients who have relapsed and have received at least two prior lines of treatment. The announcement was eagerly anticipated, especially after the FDA took some time to weigh the data presented at July’s Oncology Drug Advisory Committee (ODAC).

This is encouraging news for our community. As an IV infusion like Sarclisa or Kyprolis, Blenrep provides an additional off‑the‑shelf treatment option that can help more people access care from their doctor’s office or cancer center. Also, unlike CAR T or bispecific therapy, patients can begin treatment without hospitalization needed to manage certain side effects like CRS or ICANS.

What to Expect with Blenrep

Clinical trial data showed how safe and effective Blenrep (in combination with Velcade and dexamethasone) was for patients compared to Darzalex, Velcade, and dexamethasone. Here were the highlights:

Next Steps for Patients

Now that Blenrep is available, it is important to have a conversation with your care team if this treatment could be a viable option for you. Here are some questions to ask that help start the discussion:

In addition to your care team, the MMRF Patient Navigation Center can offer support in answering these questions and give one‑on‑one guidance tailored for  you. The MMRF Education Hub also offers additional materials to help better understand treatment options and navigate you along your myeloma journey.