Rob Miani joined the MMRF team as Chief Financial Officer in 2016. Most recently he was the Vice President of Finance and Corporate Controller of Aptuit, LLC, a global contract research organization providing integrated early discovery to mid-phase drug development services in the pharmaceutical industry. Rob has over 20 years of leadership experience in the private and public sectors, holding managerial positions in the renewable energy, private equity, Internet and technology industries, including Davenport Newberry, Oak Investment Partners and INT Media Group. He began his career with Arthur Anderson LLP in the Assurance and Business Advisory Services Division. Rob is a CPA and received his BS degree in Accounting from Fairfield University.
3/20/21 Patient Summit – Top FAQs
Should myeloma patients get vaccinated against COVID-19 and if so, when?
Yes, myeloma patients should get any of the three COVID-19 vaccines available (that is, the Pfizer, Moderna, or the J&J vaccine). Myeloma specialists do not have any specific guidance on the exact timing (that is, before treatment, during treatment, after treatment, during maintenance, etc.) with the exception of patients who have had an autologous stem cell transplant (ASCT) or chimeric antigen receptor (CAR) T-cell therapy. For these patients, guidance on vaccination is similar to what is advised for the influenza vaccine which is to wait until 3 months after your ASCT or CAR T-cell therapy to get vaccinated. For all other myeloma patients, myeloma specialists are recommending that if you are offered a chance to get vaccinated, you should take the offer and get it when you can.
As always, myeloma patients should still practice social distancing, masking, and handwashing especially until the number of COVID-19 cases go down.
When should a myeloma patient get an autologous stem cell transplant?
There have been a large number of trials that have investigated the benefit of autologous stem cell transplant (ASCT) as part of the initial treatment regimen (early) compared with ASCT after a patient has relapsed (late). One of the more recent studies to be published showed that patients who got an early transplant tended to have a longer time without relapse than did those who got a late transplant; however, survival time (that is, how long patients lived) was similar between groups. The results of this trial had many patients and myeloma experts asking: if survival is the same, why should patients undergo ASCT early? Why not observe how long a patient responds to initial therapy and then if the patient relapses, do an ASCT at that time?
The decision to proceed with an ASCT early or late is based on the recommendation of your physician and your understanding of the role of ASCT. Patients should know that ASCT is a choice and not a necessity! To help answer the question of when a myeloma patient should get an ASCT, it is helpful to weigh the advantages and disadvantages of each:
Early transplant
- Advantages
- The patient is the youngest and healthiest they’ll ever be
- The myeloma will be at its most sensitive
- The patient will experience the quickest recovery (or return to “new normal”)
- Disadvantages
- About 10% to 15% of patients may not need it
- About 20% of patients will relapse within 2 years
- There is a 1% risk of serious, life-threatening complications
- Recovery takes about 3 months
- No proven impact on survival
Late transplant
- Advantages
- The patient will be able to conserve their quality of life and have minimal disruption to their current lifestyle
- The patient can hedge their bet against future relapse (that is, better treatments may be available later on)
- Disadvantages
- About 60% to 70% of patients will relapse from their initial treatment and will need ASCT within 2 to 3 years
- Recovery will be harder than after an early transplant
Ultimately, patients and their doctors should consider specific factors relating to their disease burden, comorbidities (like diseases that affect the heart, lung, liver, or kidneys), and other personal factors when making the decision on when to undergo ASCT. For example, if a patient has a high disease burden and high-risk features at diagnosis, then an ASCT is warranted in order to treat the myeloma as aggressively as possible early on in the disease course. Alternatively, if a patient has standard-risk disease and has had a major response to initial therapy, waiting for an ASCT until relapse may be the best option.
Are myeloma patients with high-risk disease treated differently than patients with standard-risk disease?
Risk assessment in myeloma patients is typically based on a set of clinical factors such as results from routine blood tests that include beta-2 microglobulin, albumin, and lactate dehydrogenase. In addition to these blood tests, routine cytogenetic analysis of myeloma cell chromosomes by fluorescence in situ hybridization (FISH) provides information on whether a patient has chromosomal abnormalities (such as chromosomal deletions or translocations). Patients with high levels of the routine blood markers and the presence of chromosomal abnormalities are considered high-risk and this group of patients, overall, is associated with the poorest outcomes. Unfortunately, treatment advancements made in myeloma have not helped to improve outcomes for patients considered high risk. High-risk patients typically do not have a long-lasting response to initial therapy (that is, they relapse quickly following treatment).
There is no standard treatment approach for high-risk patients and most myeloma experts will pursue an aggressive treatment plan typically consisting of a 4-drug induction regimen followed by autologous stem cell transplantation (ASCT) and combination maintenance therapy (typically Revlimid plus one other agent). Alternately, high-risk patients are encouraged to enroll in a clinical trial. One trial that is enrolling high-risk patients is the MMRC MyDRUG trial. In this trial, patients considered functionally high-risk—that is, they have relapsed less than 18 months since initial therapy (and no ASCT) or less than three years on maintenance therapy with Revlimid following ASCT – undergo genome sequencing, a test that analyzes a patient’s myeloma genetic structure and can reveal the presence of cancer-related mutations. Based on the results, patients are matched to a specific treatment that targets their unique myeloma mutation and assigned to a branch of the MyDRUG trial that is studying that treatment. In addition to receiving the specific, mutation-matched treatment, all patients are given the standard-of-care regimen of Ninlaro + Pomalyst + dexamethasone. High-risk patients with no mutations detected receive a four-drug combination that includes Ninlaro-Pomalyst-dexamethasone and Darzalex, Xpovio, or Blenrep—a treatment that is otherwise unavailable. To learn more about joining the MyDRUG trial, contact a Patient Navigator at the MMRF Patient Support Center at 888-841-6673.
MMRF Patient Summit 3/20/21
This web conference provides multiple myeloma patients and their families and caregivers the most up-to-date information on myeloma management from doctors and other experts in the field. View Patient Summit now.
