Elranatamab for Multiple Myeloma

Not currently recruiting at 135 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Smoldering myeloma, Plasma cell leukemia, Amyloidosis, POEMS, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Elranatamab, a new treatment for people with multiple myeloma, a type of blood cancer that has returned or hasn't responded to other treatments. Elranatamab helps the immune system attack cancer cells. The trial aims to determine if this treatment can be effective on its own. It may suit those diagnosed with multiple myeloma who have tried other treatments without success. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to explore new options.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have taken an investigational drug within 30 days before starting the trial.

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

Research has shown that elranatamab is generally safe for patients with relapsed or refractory multiple myeloma. Studies have found that patients treated with elranatamab responded well and did not encounter any new safety issues. In one study, patients tolerated the treatment well even after more than a year. Another study confirmed that patients did not experience unexpected side effects compared to other similar treatments. Overall, evidence suggests that elranatamab is relatively safe, with side effects similar to those of other multiple myeloma treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Elranatamab is unique because it targets multiple myeloma using a bispecific antibody approach, specifically a BCMA-CD3 bispecific antibody. This means it can engage two different targets: BCMA on myeloma cells and CD3 on T-cells, effectively recruiting the body's immune system to attack the cancer cells. Most current treatments, like proteasome inhibitors or immunomodulatory drugs, don't use this dual-target strategy. Researchers are excited because this innovative mechanism could offer more effective and targeted treatment against multiple myeloma, potentially leading to better outcomes for patients.

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

Research has shown that Elranatamab, a type of antibody treatment, holds promise for treating relapsed or hard-to-treat multiple myeloma. In the MagnetisMM-3 study, patients experienced strong and lasting improvements, with significant reductions in cancer symptoms over an extended period. Another analysis found that 61 out of 100 patients responded positively to the treatment. Additionally, the median time during which the cancer did not worsen was about 17.2 months. These findings suggest that Elranatamab could be an effective option for people with this challenging condition. Participants in this trial will be assigned to one of the treatment arms, either cohort A or cohort B, both involving Elranatamab. ^{6 7 8 9 10}

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 haven't responded to at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 antibody. Participants should have measurable disease, be in stable condition, not pregnant, willing to use contraception, and without other active cancers or serious infections. There are two groups: those who've had BCMA-targeted therapy before and those who haven't.

Inclusion Criteria

Not pregnant and willing to use contraception

I have been diagnosed with multiple myeloma.

Any side effects from my previous treatments have mostly gone away.

Exclusion Criteria

Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

I had a stem cell transplant less than 3 months ago.

I have been diagnosed with amyloidosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Elranatamab monotherapy to evaluate clinical benefit in relapsed/refractory multiple myeloma

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

up to approximately 20.14 months

What Are the Treatments Tested in This Trial?

Interventions

• Elranatamab (PF-06863135)

Trial Overview The study tests Elranatamab as a single treatment for relapsed/refractory multiple myeloma. It's a bispecific antibody that directs the body's T-cells to attack the cancer cells by recognizing both T-cell markers (CD3) and myeloma cell markers (BCMA). The goal is to see if this targeted approach can help control the disease.

How Is the Trial Designed?

Group I: Elranatamab (cohort B) Experimental Treatment 1 Intervention

BCMA-CD3 bispecific antibody

Group II: Elranatamab (cohort A) Experimental Treatment 1 Intervention

BCMA-CD3 bispecific antibody

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

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

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]

Elotuzumab, when combined with lenalidomide and dexamethasone, significantly improves progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma, with a median PFS of 19.4 months compared to 14.9 months for the standard treatment.

The treatment showed a higher overall response rate (ORR) of 75.8% versus 65.5% for the standard therapy, although serious adverse reactions were more common in the elotuzumab group (65% vs. 57%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma. Gormley, NJ., Ko, CW., Deisseroth, A., 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 3 study involving 646 patients with relapsed or refractory multiple myeloma, the combination of elotuzumab, lenalidomide, and dexamethasone significantly improved progression-free survival, with a median of 19.4 months compared to 14.9 months for the control group.

The overall response rate was also higher in the elotuzumab group at 79% versus 66% in the control group, indicating that elotuzumab enhances the effectiveness of standard treatment for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. Lonial, S., Dimopoulos, M., Palumbo, A., et al.[2022]

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]

Elotuzumab, when combined with other treatments, significantly improved progression-free survival (PFS) by 14% and overall survival (OS) by 20% in multiple myeloma patients, based on a review of five randomized control trials involving 1,763 participants.

While Elotuzumab showed efficacy in relapsed/refractory multiple myeloma, it also increased the risk of serious adverse events, infections, and cardiac disorders, indicating a need for careful monitoring in patients receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Elotuzumab combination therapy for patients with multiple myeloma: A systematic review and meta-analysis. Noori, M., Fayyaz, F., Rezaei, N.[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]

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]

Elotuzumab is an FDA-approved monoclonal antibody for multiple myeloma that targets SLAMF7, a protein found on myeloma and natural killer cells, enhancing the immune response against cancer cells.

In clinical trials, elotuzumab showed strong efficacy and a good safety profile when used with other treatments like immunomodulatory drugs and proteasome inhibitors, making it a promising option for multiple myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab for the treatment of multiple myeloma. Wang, Y., Sanchez, L., Siegel, DS., et al.[2022]

Citations

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

Comparison of outcomes with elranatamab and real world ... Clinical outcomes in the ECA were poor (median PFS 3.71 months [95% confidence interval (CI) 2.73-4.73], median OS 11.00 months [8.02-18.10]).

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

Comparison of outcomes with elranatamab and real world ... Clinical outcomes in the ECA were poor (median PFS 3.71 months [95% confidence interval (CI) 2.73–4.73], median OS 11.00 months [8.02–18.10]).

3. 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).

4. actaoncologicaturcica.com actaoncologicaturcica.com/articles/elranatamab-in-heavily-pretreated-triple-class-refractory-multiple-myeloma-a-single-center-experience/ahot.galenos.2025.2025-5-5

Elranatamab in Heavily Pretreated Triple-class Refractory ... Elranatamab demonstrated promising clinical efficacy and an acceptable safety profile in a heavily pretreated TCR-MM population. The elevated ...

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. ashpublications.org ashpublications.org/blood/article/146/16/1929/546367/Safety-and-efficacy-of-elranatamab-in-patients

Safety and efficacy of elranatamab in patients with relapsed ... Elranatamab elicits deep and rapid heme responses in patients with relapsed AL amyloidosis, including minimal residual disease negativity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11269363/

Long‐term survival and safety of elranatamab in patients with ... Long‐term survival and safety of elranatamab in patients with relapsed or refractory multiple myeloma: Update from the MagnetisMM‐3 study

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

Efficacy and safety of elranatamab (PF-06863135), a B-cell ... Initial safety results for MagnetisMM-3: A phase 2 trial of elranatamab, a B-cell maturation antigen (BCMA)-CD3 bispecific antibody, in patients ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2531137923009409

ELRANATAMAB, A B-CELL MATURATION ANTIGEN-CD3 ... Elranatamab remains efficacious and well tolerated in pts with RRMM after >1 y of follow-up. Updated analysis with a median follow-up of ≍15 mo, the longest of ...

10. clinical-lymphoma-myeloma-leukemia.com clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(23)01447-7/fulltext

MM-374 Efficacy and Safety of Elranatamab in Patients ... Elranatamab was efficacious and well tolerated in patients with RRMM and prior exposure to BCMA-directed therapies. No new safety signals were observed vs the ...