944 Participants Needed

Elranatamab Combinations for Multiple Myeloma

(MAGNETISMM-5 Trial)

Recruiting at 313 trial locations
PC
Overseen ByPfizer CT.gov Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

PC

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

I have been diagnosed with multiple myeloma.
You have certain levels of abnormal proteins in your blood or urine, or abnormal levels of certain proteins in your blood.
I have been treated for multiple myeloma with lenalidomide and a proteasome inhibitor.
See 3 more

Exclusion Criteria

I have been treated with a BCMA-targeted therapy before.
I have been diagnosed with amyloidosis.
I do not have any active infections like HBV, HCV, HIV, or uncontrolled bacterial, fungal, or viral infections.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Safety Lead-In Dose Escalation

Assessment of safety and activity of different doses of elranatamab in combination with daratumumab

8-12 weeks

Part 2: Randomized Treatment

Participants receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone until disease progression or unacceptable side effects

Until disease progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Daratumumab
  • Dexamethasone
  • Elranatamab
  • Pomalidomide
Trial Overview The study tests elranatamab alone or combined with daratumumab against a known combo of daratumumab, pomalidomide & dexamethasone in relapsed/refractory multiple myeloma patients. It's divided into parts: assessing safety and activity of different doses; comparing these treatments; evaluating alternative dosing schedules.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Active Control
Group I: Part 3 Arm E: Elranatamab + DaratumumabExperimental Treatment2 Interventions
Group II: Part 3 Arm D: ElranatamabExperimental Treatment1 Intervention
Group III: Part 2 Randomized Arm B: Elranatamab + DaratumumabExperimental Treatment2 Interventions
Group IV: Part 2 Randomized Arm A: ElranatamabExperimental Treatment1 Intervention
Group V: Part 1 Safety Lead-In Dose Escalation: Elranatamab + DaratumumabExperimental Treatment2 Interventions
Group VI: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + DexamethasoneActive Control3 Interventions

Daratumumab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Darzalex for:
🇺🇸
Approved in United States as Darzalex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Daratumumab, a monoclonal antibody targeting CD38, has shown significant efficacy as a monotherapy in relapsed/refractory multiple myeloma, achieving an overall response in about one-third of patients, with rapid and durable effects.
In combination with other treatments like bortezomib or lenalidomide, daratumumab significantly prolonged progression-free survival, although the overall survival benefit is still being evaluated, and it was generally well tolerated with manageable side effects.
Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma.Blair, HA.[2018]
Daratumumab, a monoclonal antibody targeting CD38, has been approved in the USA for treating multiple myeloma in patients who have undergone at least three prior therapies, demonstrating its role as a treatment option for difficult-to-treat cases.
In a phase II trial, daratumumab monotherapy showed an overall response rate of about 30% in patients with relapsed or refractory multiple myeloma, indicating its efficacy in this challenging patient population.
Daratumumab: First Global Approval.McKeage, K.[2018]
Daratumumab is a monoclonal antibody that effectively targets CD38 on multiple myeloma cells, leading to cell death through various mechanisms such as complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity.
It has shown a favorable safety profile and significant clinical activity as both a standalone treatment and in combination with lenalidomide for patients with relapsed multiple myeloma who have not responded to other therapies.
Daratumumab: monoclonal antibody therapy to treat multiple myeloma.Xia, C., Ribeiro, M., Scott, S., et al.[2018]

Citations

Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. [2018]
Daratumumab: First Global Approval. [2018]
Daratumumab: monoclonal antibody therapy to treat multiple myeloma. [2018]
Daratumumab: A Review in Combination Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma. [2021]
Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. [2022]
How to Integrate Elotuzumab and Daratumumab Into Therapy for Multiple Myeloma. [2018]
Daratumumab for the Treatment of Multiple Myeloma: A Review of Clinical Applicability and Operational Considerations. [2022]
Monoclonal Antibodies in Multiple Myeloma: A New Wave of the Future. [2018]
Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. [2023]
Elranatamab: First Approval. [2023]
Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case. [2023]
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