What is Darzalex?
Darzalex™, also known as daratumumab, is the first monoclonal antibody approved for use in multiple myeloma. Darzalex is made by Janssen Biotech and Genmab.
How is Darzalex used?
Darzalex™ (daratumumab, Janssen/Genmab) is a monoclonal antibody. It is approved for use in the treatment of multiple myeloma patients:
What types of patients can benefit from Darzalex?
Darzalex has been studied in newly diagnosed patients and also in patients with relapsed and/or refractory myeloma including:
How does Darzalex work?
Darzalex binds to CD38, a marker found on the surface of myeloma cells. It is thought to inhibit myeloma cell growth in several ways, including by directly affecting myeloma cells and by enabling immune cells to kill myeloma cells.
How is Darzalex administered?
Darzalex™ (daratumumab, Janssen/Genmab) is given as an intravenous (IV) infusion into a vein. It is typically given at a dose of 16 mg/kg of body weight and is administered weekly during Weeks 1 through 8, every two weeks during Weeks 9 through 24, and then every 4 weeks until disease progression.
Before receiving Darzalex, patients receive premedication with antihistamines, fever-reducing agents, and steroids to reduce the risk of infusion reactions. Following the infusion of Darzalex, patients also receive a steroid to reduce the risk of delayed infusion reactions.
Patients receiving Darzalex also receive medication to prevent shingles, a viral infection that causes a painful rash and is due to a reactivation of the virus that causes chickenpox (herpes zoster virus).
What are Darzalex side effects?
In clinical studies, the most common side effects seen with Darzalex™ (daratumumab, Janssen/Genmab) included:
How are side effects of Darzalex managed?
Can Darzalex affect laboratory testing?
As Darzalex is an IgG monoclonal antibody, it can be detected on tests used for the clinical monitoring of M protein and may impact the determination of complete response and of disease progression in some patients with IgG myeloma
What have Darzalex clinical trials shown?
The efficacy of Darzalex™ (daratumumab, Janssen/Genmab) in combination with Velcade, Melphalan, and Prednisone in newly diagnosed patients who are not eligible for stem cell transplant was shown in a phase III clinical trial. The ALCYONE study included 706 patients who were newly diagnosed with multiple myeloma but not eligible for stem cell transplant due to age or frailty. All patients received Velcade, Melphalan, and Prednisone (VMP); one half of the patients also received IV Darzalex at 16 mg/kg (D-VMP).
The safety and efficacy of Darzalex™ (daratumumab, Janssen/Genmab) was demonstrated in two Phase 1/2 clinical trials in heavily-pretreated relapsed and/or refractory myeloma. The SIRIUS study included 106 patients who had received at least 3 prior therapies, including a proteasome inhibitor and an IMiD, or who were refractory to both a proteasome inhibitor and an IMiD. Patients received intravenous (IV) Darzalex at a dose of 16 mg/kg.
The GEN501 study evaluated different doses of Darzalex in patients who had received at least 2 prior therapies. Thirty patients received IV Darzalex at a dose of 8 mg/kg and 42 patients received IV Darzalex at a dose of 16 mg/kg. In patients receiving the 16 mg/kg dose:
What other Darzalex combinations have been evaluated?
Darzalex is being evaluated in an ongoing multicenter Phase Ib study (MMY 1001) in combination with various myeloma therapies in newly diagnosed and relapsed and/or refractory myeloma.
How is Darzalex currently being studied in myeloma?
Darzalex is being evaluated when added to various combination therapies in four Phase 3 studies in the United States.
In relapsed and/or refractory myeloma, Darzalex is being evaluated in two fully-enrolled trials:
In newly diagnosed myeloma, Darzalex is being evaluated:
Single-agent Darzalex is also being made available as part of an expanded access program (EAP) study for patients with relapsed and/or refractory myeloma. The Multiple Myeloma Research Consortium (MMRC) is currently collaborating with Janssen on this study, which provides access to Darzalex treatment for patients who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD®, Celgene) or whose disease is refractory to both a PI and an IMiD, and who are not eligible for or who do not have access to enrollment in another Darzalex study. LEARN MORE
Interested in learning more about Darzalex clinical trials? Talk to an MMRF Patient Support Nurse to learn more or use our clinical trials finder: