Elranatamab for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Noopur Raje, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Massachusetts General Hospital

Must not be taking: Anti-BCMA antibodies

Disqualifiers: Active infections, Cardiovascular diseases, Other malignancy, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.

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 to get specific guidance based on your situation.

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

Elranatamab has shown promising results in clinical trials for multiple myeloma, with a significant number of patients responding to the treatment. In the MagnetisMM-1 trial, 63.6% of patients experienced a positive response, and the drug demonstrated durable responses and manageable safety, offering hope for those with relapsed or refractory multiple myeloma. ^{1 2 3 4 5}

Is Elranatamab safe for humans?

Elranatamab has been tested in clinical trials for multiple myeloma, and while no dose-limiting toxicities were observed, some patients experienced side effects like low blood cell counts and cytokine release syndrome (a reaction that can cause fever and flu-like symptoms). Overall, it showed manageable safety and promising results for patients. ^{1 2 3 6 7}

How is the drug Elranatamab different from other treatments for 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. This mechanism is different from traditional treatments and offers a new option for patients who have already tried multiple other therapies. ^{1 2 3 7 8}

Research Team

Noopur Raje, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults with relapsed and refractory multiple myeloma who have previously been treated with idecabtagene vicleucel. Participants must be over 18, agree to use contraception, have measurable disease per specific criteria, good organ/marrow function, an ECOG status ≤1, and a heart ejection fraction ≥40%. Exclusions include recent live vaccines or investigational drugs, certain MM-related conditions or cardiovascular issues within the last 6 months.

Inclusion Criteria

Participant has given voluntary signed written informed consent before performance of any study related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care

Your heart's pumping function, measured by a heart scan or ultrasound, is at least 40%.

I have multiple myeloma that came back or didn't respond after receiving idecabtagene vicleucel.

Exclusion Criteria

Patients with specific MM-related conditions are excluded from this trial

You are currently taking any other experimental drugs for this condition.

Previous administration with an investigational drug within a specific timeframe

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elranatamab subcutaneous injections for up to 6 months

6 months

Cycle 1: Days 1, 4, 8, 15, 22; Cycle 2: Days 1, 8, 15, 22; Cycles 3-6: Days 1, 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Long-term follow-up

Participants are followed for progression-free survival and overall survival

Up to 5 years

Treatment Details

Interventions

• Elranatamab (CAR T-cell Therapy)

Trial Overview The trial is testing elranatamab's effectiveness in reducing the risk of disease progression in patients with multiple myeloma after treatment with idecabtagene vicleucel. It aims to see if this drug can help when the cancer comes back or doesn't respond to previous treatments.

Participant Groups

Group I: Elranatamab Experimental Treatment 1 Intervention

Elranatamab subcutaneous injections at pre-determined doses, administered at the following timepoints during each 28-day cycle: Cycle 1: Days 1, 4, 8, 15, and 22; Cycle 2: Days 1, 8, 15, and 22 ; Cycles 3-6: Days 1 and 15

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Beth-Israel Deaconess Medical Center Boston, MA

Massachusetts General Hospital Boston, MA

Dana-Farber Cancer Institute Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3066

Patients Recruited

13,430,000+

Pfizer

Industry Sponsor

Trials

4712

Patients Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elranatamab: First Approval. Dhillon, S.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. Bahlis, NJ., Costello, CL., Raje, NS., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elrexfio™ (elranatamab-bcmm): The game-changer in treatment of multiple myeloma. Rais, T., Khan, A., Riaz, R.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse. Bhutani, M., Foureau, DM., Robinson, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New investigational drugs with single-agent activity in multiple myeloma. Rajan, AM., Kumar, S.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case. Mutlu, YG., Yıgıt Kaya, S., Maral, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Lesokhin, AM., Tomasson, MH., Arnulf, B., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Elranatamab: First Approval. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Elrexfio™ (elranatamab-bcmm): The game-changer in treatment of multiple myeloma. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

New investigational drugs with single-agent activity in multiple myeloma. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Pooled analysis of the reports of carfilzomib, panobinostat, and elotuzumab combinations in patients with refractory/relapsed multiple myeloma. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. [2023]