Elranatamab for Multiple Myeloma

Recruiting at 113 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

187 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Elranatamab, a drug that helps the immune system target and kill cancer cells, in patients with a type of blood cancer that hasn't responded to other treatments. The drug works by connecting immune cells to cancer cells so they can be destroyed.

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.

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

Elranatamab has shown promising results in treating multiple myeloma, with a study reporting a 63.6% response rate and 38.2% of patients achieving complete response or better. The drug was effective even in patients who had received prior treatments, with a median duration of response of 17.1 months and manageable safety profile. ^{1 2 3 4 5}

Is Elranatamab safe for humans?

In a clinical trial for multiple myeloma, Elranatamab was found to have manageable safety with no dose-limiting toxicities observed. Some patients experienced side effects like low blood cell counts (cytopenias) and a reaction called cytokine release syndrome, but these were considered manageable. ^{1 2 4 6 7}

What makes the drug Elranatamab unique for 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, including those who have had prior BCMA-directed therapy. ^{1 2 4 8 9}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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, 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]

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]

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 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 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 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]

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

Safety and efficacy of Elotuzumab combination therapy for patients with multiple myeloma: A systematic review and meta-analysis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. [2022]

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

FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma. [2018]

7. 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]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Elotuzumab for the treatment of multiple myeloma. [2022]