Elranatamab for Multiple Myeloma

Recruiting at 2 trial locations

Overseen By Noopur Raje, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Anti-BCMA antibodies

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug elranatamab, a type of antibody therapy, can slow the progression of multiple myeloma, a type of blood cancer, after treatment with idecabtagene vicleucel. Participants receive regular subcutaneous injections of elranatamab over several cycles. The trial seeks patients whose multiple myeloma has returned or not responded after at least four different therapies, including idecabtagene vicleucel. Those who have undergone these treatments and still have measurable disease may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that elranatamab is likely to be safe for humans?

Research has shown that elranatamab generally has a manageable safety profile. In one study, about 30% of patients achieved a complete response, with no signs of multiple myeloma in their blood or urine. This suggests the drug could be effective without causing serious harm.

Previous research also found that elranatamab is usually well-tolerated. Although some side effects were reported, most were manageable, allowing most participants to continue treatment without major issues.

Overall, while all treatments carry some risks, elranatamab has shown promising safety results in earlier studies. Prospective trial participants should discuss any concerns with their healthcare provider to determine if this treatment is suitable for them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Elranatamab is unique because it targets multiple myeloma cells through a new mechanism of action called bispecific T-cell engager (BiTE) technology. Unlike traditional treatments like proteasome inhibitors or immunomodulatory drugs, Elranatamab bridges T-cells and myeloma cells, effectively recruiting the body's own immune system to attack the cancer cells directly. This innovative approach could potentially lead to more effective outcomes and offers a new hope for patients who may not respond well to existing therapies.

What evidence suggests that elranatamab might be an effective treatment for multiple myeloma?

Research has shown that elranatamab, the investigational treatment in this trial, holds promise for patients with relapsed or refractory multiple myeloma. In the MagnetisMM-3 study, patients exhibited strong and lasting responses to the treatment. Specifically, 61% of patients experienced a significant decrease in cancer activity, indicating that more than half saw improvement. Additionally, elranatamab outperformed treatments typically used in real-world settings. These findings suggest that elranatamab could be an effective option for managing multiple myeloma when other treatments have failed. ^{1 6 7 8 9}

Who Is on the Research Team?

Noopur Raje, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Elranatamab

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Pfizer

Industry 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

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

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.

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]

Elranatamab, a bispecific antibody targeting BCMA and CD3, has shown promising results in treating relapsed refractory multiple myeloma, but its effectiveness in cases with central nervous system (CNS) involvement was previously unclear.

In a reported case, a 37-year-old male patient with CNS involvement of multiple myeloma was successfully treated with Elranatamab, suggesting potential for this therapy in challenging CNS-MM cases.

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]

The treatment landscape for multiple myeloma (MM) has significantly improved, with four new drugs approved in 2015 alone, leading to better patient outcomes than seen in any other cancer over the past decade.

Several new investigational agents, such as Isatuximab and marizomib, show promising efficacy in clinical trials, indicating a strong potential for future regulatory approval and further advancements in MM treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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.

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]

In the MagnetisMM-1 trial involving 88 patients with relapsed or refractory multiple myeloma, elranatamab demonstrated a significant overall response rate of 63.6%, with 38.2% of patients achieving a complete response or better, indicating its efficacy even in heavily pre-treated patients.

Elranatamab showed manageable safety with no dose-limiting toxicities during dose escalation, although some patients experienced cytopenias and cytokine release syndrome; the median progression-free survival was 11.8 months and overall survival was 21.2 months, suggesting promising durability of responses.

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]

In a phase II study involving 15 patients with relapsed multiple myeloma, the combination of elotuzumab with carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) showed a 46.7% rate of achieving very good partial response (≥VGPR) after 4 cycles of treatment, indicating significant efficacy in a challenging patient population.

The treatment was well-tolerated with no new safety concerns reported, and the overall response rate was 80%, suggesting that Elo-KRd is a promising option for patients with high-risk and lenalidomide-refractory multiple myeloma.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

ELREXFIO™ (elranatamab-bcmm) is an FDA-approved bispecific antibody that effectively targets both CD3 and BCMA, activating T-cells to attack multiple myeloma cells, which is crucial for patients with relapsed or refractory cases.

Clinical trials, including MagnetisMM-3, have shown significant response rates and long-term tolerability for ELREXFIO, indicating its potential to improve treatment outcomes for patients suffering from this challenging cancer.

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]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40826257/

Population Exposure-Response Efficacy Analysis of ...

Results from the MagnetisMM-3 study indicated deep and durable responses in patients with relapsed or refractory multiple myeloma (RRMM).

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40491859/

An Updated Indirect Comparison of Elranatamab Versus a ...

Patients treated with elranatamab exhibited significantly better clinical outcomes compared with treatments currently used in real-world clinical practice.

3.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14624-9

Comparison of outcomes with elranatamab and real world ...

This study aimed to characterise outcomes for real world TCE RRMM patients and to estimate the treatment effect of elranatamab compared to ...

4.

elrexfio.com

elrexfio.com/results

ELREXFIO® (elranatamab-bcmm) Results | Safety Info

In Group A, results with ELREXFIO showed: 26% of people had a CR or better: Multiple myeloma could not be detected in the blood or urine after treatment. 26% of ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7549

A US subgroup analysis from MagnetisMM-3.

With a median follow‐up of 33.9 mo, ORR was 61.0%, mPFS was 17.2 mo, and mOS was 24.6 mo. Here we report results for the subgroup of pts ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12454520/

Elranatamab Fixed Dosing: A Safe, Effective, and Convenient ...

The primary efficacy and safety results of the MagnetisMM-3 trial were previously reported [16]. The primary end point was confirmed by ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.8006

Efficacy and safety of elranatamab (PF-06863135), a B-cell ...

Conclusions: Elranatamab demonstrated a manageable safety profile, and SC doses ≥215μg/kg achieved ORR of 75% with CR/sCR rate of 30%. These ...

8.

nature.com

nature.com/articles/s41591-023-02528-9

Elranatamab in relapsed or refractory multiple myeloma

The results of this study are consistent with results reported from the phase 1 MagnetisMM-1 study in which a response rate of 64% and a median ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40713551/

Comparison of outcomes with elranatamab and real world ...

This study provides recent real world evidence of poor outcomes in TCE RRMM in the UK. PFS was longer among patients who received ...