80 Participants Needed

Elranatamab Access for Multiple Myeloma

(MagnetisMM15 Trial)

Recruiting at 13 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Pfizer
Must be taking: Elranatamab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Elranatamab for treating multiple myeloma?

Elranatamab has shown promising results in clinical trials for treating relapsed or refractory multiple myeloma, with significant response rates and long-term tolerability. In the MagnetisMM-1 trial, 63.6% of patients responded to the treatment, and in the MagnetisMM-3 trial, 61.0% of patients achieved a confirmed response, indicating its effectiveness in managing this condition.12345

How is the drug Elranatamab unique in treating multiple myeloma?

Elranatamab is unique because it is a bispecific antibody that targets both BCMA on myeloma cells and CD3 on T cells, activating the T cells to attack the cancer cells. It is administered subcutaneously and has shown promising results in patients who have already undergone multiple other treatments, offering a new option for those with relapsed or refractory multiple myeloma.13456

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for people with Multiple Myeloma who are benefiting from Elranatamab in ongoing Pfizer studies. They must agree to follow reproductive safety measures and cannot join if they've left the original study or have conditions that increase risk or suicidal thoughts recently.

Inclusion Criteria

Participants must agree to follow the reproductive criteria as outlined in the protocol
I was part of a study for elranatamab, still taking it when the study ended, and it's working for me.

Exclusion Criteria

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elranatamab monotherapy until disease progression, unacceptable toxicity, withdrawal of consent, study termination, or commercial availability

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Elranatamab
Trial OverviewThe study provides continued access to Elranatamab, a medication under investigation, for participants who were part of previous trials (Parent Studies) and are still seeing positive effects from the treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ElranatamabExperimental Treatment1 Intervention
Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

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

Findings from Research

Elranatamab is a bispecific T cell engager that targets BCMA on multiple myeloma cells, effectively activating T cells to kill these cancer cells, and has received its first approval in the USA for treating adult patients with relapsed or refractory multiple myeloma after at least four prior therapies.
The approval was based on the drug's response rate and durability of response, with ongoing studies required to confirm its clinical benefits, indicating a promising new option for patients with difficult-to-treat multiple myeloma.
Elranatamab: First Approval.Dhillon, S.[2023]
In a review of 20 studies involving 2220 patients with relapsed/refractory multiple myeloma, carfilzomib combinations showed a high overall response rate of 61%, with 29% achieving at least a very good partial response.
Elotuzumab combinations were particularly effective, with a 73% overall response rate and 37% achieving at least a very good partial response, although patients experienced significant nonhematologic adverse events like cardiac issues and pneumonia.
Pooled analysis of the reports of carfilzomib, panobinostat, and elotuzumab combinations in patients with refractory/relapsed multiple myeloma.Liu, L., Zhao, N., Xu, W., et al.[2018]
In the phase 2 MagnetisMM-3 trial, elranatamab demonstrated a confirmed objective response rate of 61.0% in patients with relapsed or refractory multiple myeloma, indicating its efficacy as a treatment option.
The safety profile of elranatamab was manageable, with a reduction in grade 3-4 adverse events when switching from weekly to biweekly dosing, suggesting that this adjustment may enhance long-term safety without affecting treatment effectiveness.
Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results.Lesokhin, AM., Tomasson, MH., Arnulf, B., et al.[2023]

References

Elranatamab: First Approval. [2023]
Pooled analysis of the reports of carfilzomib, panobinostat, and elotuzumab combinations in patients with refractory/relapsed multiple myeloma. [2018]
Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. [2023]
Elrexfio™ (elranatamab-bcmm): The game-changer in treatment of multiple myeloma. [2023]
Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. [2023]
Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case. [2023]