Elranatamab Combinations for Multiple Myeloma
(MAGNETISMM-5 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab.People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have had anti-CD38 therapy within 6 months before the trial or any investigational product within 30 days before the trial.
What safety data is available for Elranatamab combinations in treating multiple myeloma?
The safety data for Elranatamab combinations in treating multiple myeloma can be inferred from studies on Daratumumab, a monoclonal antibody targeting CD38, which is often used in combination with other agents like dexamethasone and pomalidomide. Daratumumab has shown a favorable toxicity profile with common adverse events being hematological, such as neutropenia and lymphopenia. Infusion-related reactions are also noted, but overall, it has an acceptable safety profile both as a monotherapy and in combination therapies. The safety data for Elranatamab specifically may not be directly available, but similar monoclonal antibodies like Daratumumab provide a basis for understanding potential safety considerations.12345
Is the drug Daratumumab, Elranatamab a promising treatment for multiple myeloma?
Yes, Daratumumab, Elranatamab is a promising treatment for multiple myeloma. Elranatamab has shown strong results in clinical trials, with a high response rate and long-lasting effects in patients who have tried other treatments. It has been approved in the USA and is being reviewed in other countries. Daratumumab has also been effective, especially when combined with other drugs, providing deep and lasting responses.678910
What data supports the idea that Elranatamab Combinations for Multiple Myeloma is an effective drug?
The available research shows that Daratumumab, a part of the Elranatamab Combinations for Multiple Myeloma, is effective in treating multiple myeloma. Studies have shown that when used alone or with other drugs like lenalidomide and dexamethasone, it helps patients who have relapsed or have not responded to other treatments. In one study, about 30% of patients responded positively to Daratumumab alone. When combined with other drugs, it significantly increased the time patients lived without the disease getting worse. It also improved some aspects of patients' quality of life. Compared to other treatments, Daratumumab has shown deep and lasting responses, making it a valuable option for patients with multiple myeloma.1371011
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults with multiple myeloma who've had prior treatments including lenalidomide and a proteasome inhibitor. They should have measurable disease, be in relatively good health (ECOG ≤2), not pregnant, and willing to use contraception. Excluded are those with certain other conditions like amyloidosis or active infections, previous BCMA therapy, recent stem cell transplant, or live vaccines taken within the last month.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Safety Lead-In Dose Escalation
Assessment of safety and activity of different doses of elranatamab in combination with daratumumab
Part 2: Randomized Treatment
Participants receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone until disease progression or unacceptable side effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
- Dexamethasone
- Elranatamab
- Pomalidomide
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University