Elranatamab vs Lenalidomide for Multiple Myeloma

(MagnetisMM-7 Trial)

Not currently recruiting at 308 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: BCMA targeted therapy

Disqualifiers: Plasma cell leukemia, Amyloidosis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for individuals with newly diagnosed multiple myeloma, a type of blood cancer, who have already undergone a stem cell transplant. It seeks to determine whether elranatamab (an injection) is more effective than lenalidomide (a daily pill). Participants will be divided into groups to receive one of these treatments. This trial may suit those who have had multiple myeloma for some time, are recovering from a stem cell transplant, and have not yet received maintenance treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that elranatamab is generally well-tolerated by patients, with studies finding its safety profile easy to manage. In one study, 75% of patients experienced positive results without new safety issues, indicating that serious side effects are rare.

Lenalidomide has received FDA approval for treating multiple myeloma. While usually safe, some patients might experience side effects like tiredness, diarrhea, and a lower blood cell count. However, many handle it well and find it effective for managing their condition.

Overall, both elranatamab and lenalidomide have demonstrated good tolerance in people with multiple myeloma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Elranatamab because it offers a novel approach to treating multiple myeloma. Unlike standard treatments like Lenalidomide, which work by modulating the immune system, Elranatamab is a bispecific antibody that targets both the BCMA protein on myeloma cells and CD3 on T-cells, effectively directing the immune system to attack the cancer cells. This targeted mechanism can potentially lead to more precise and effective cancer cell destruction. Additionally, Elranatamab is administered via injection, which could offer convenience compared to some current oral or intravenous options.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that elranatamab, one of the treatments tested in this trial, yields promising results for treating multiple myeloma. In studies, patients whose multiple myeloma returned or did not respond to other treatments experienced strong and lasting improvements with elranatamab. Specifically, 26% of patients achieved a complete response, with no detectable cancer in blood or urine after treatment. Another study found that 61% of patients responded to the treatment, living an average of 17.2 months without disease progression.

Lenalidomide, the other treatment option in this trial, is a well-known therapy for multiple myeloma. It has been shown to help patients live longer and slow disease progression. Both treatments are well-supported by research, but elranatamab might offer more benefits for certain patient groups. ^{1 6 7 8 9}

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 individuals with newly diagnosed multiple myeloma who've had a stem cell transplant. They should have responded to initial treatment, be within specific time frames post-transplant, and agree to use contraception. Excluded are those with certain other diseases, previous BCMA therapy, uncontrolled infections or recent investigational drug use.

Inclusion Criteria

I am fully active and can carry on all my pre-disease activities without restriction.

I had a stem cell transplant for my multiple myeloma within the last 7 months.

I have a bone marrow sample from before my treatment started for testing.

Exclusion Criteria

I do not have any active, uncontrolled infections like HBV, HCV, HIV/AIDS.

I have received maintenance treatment for multiple myeloma.

My cancer has spread to my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elranatamab as an injection under the skin at the study clinic or lenalidomide orally once daily at home

Approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days after last dose

Long-term follow-up

Participants are assessed for long-term outcomes such as overall survival and progression-free survival

Approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Elranatamab
• Lenalidomide

Trial Overview

The study compares elranatamab (injected under the skin) against lenalidomide (oral pill) in patients after stem cell transplant for multiple myeloma. The goal is to see if elranatamab can outperform lenalidomide in clinical benefits over approximately five years of participation.

How Is the Trial Designed?

Group I: Arm C - Part 2 Experimental Treatment 1 Intervention

Elranatamab

Group II: Arm A - Part 1 Experimental Treatment 1 Intervention

Elranatamab

Group III: Arm B - Part 1 Active Control 1 Intervention

Lenalidomide

Group IV: Arm B - Part 2 Active Control 1 Intervention

Lenalidomide

Elranatamab is already approved in United States, European Union for the following indications:

Approved in United States as Elrexfio for:

• Relapsed or refractory multiple myeloma

Approved in European Union as Elrexfio for:

• Relapsed or refractory multiple myeloma

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 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]

Lenalidomide, when combined with dexamethasone, significantly improves time to progression in patients with multiple myeloma compared to placebo, as shown in two randomized, double-blind studies.

However, the treatment is associated with serious side effects, including increased risks of neutropenia, thrombocytopenia, and thromboembolic events, leading to its restricted distribution under the RevAssist program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy. Hazarika, M., Rock, E., Williams, G., et al.[2020]

Lenalidomide is an effective treatment for patients with relapsed or refractory multiple myeloma, showing promising clinical activity and is approved by the FDA.

Common side effects of lenalidomide include neutropenia, thrombocytopenia, and thromboembolic events, necessitating careful monitoring to prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. Tariman, JD.[2018]

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]

Lenalidomide is a powerful treatment for multiple myeloma (MM) that works by directly causing cancer cell death, preventing cancer cells from sticking to bone marrow, and enhancing the body's immune response against tumors.

In combination with dexamethasone, lenalidomide has shown superior effectiveness in clinical trials, leading to improved patient outcomes such as longer survival and FDA approval for treating relapsed MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of lenalidomide in combination with dexamethasone for the treatment of multiple myeloma. Hideshima, T., Raje, N., Richardson, PG., et al.[2021]

Lenalidomide, a derivative of thalidomide, has improved potency and a better side-effect profile, particularly with reduced neurologic toxicity compared to its predecessor.

While lenalidomide shows promise in treating conditions like myelodysplastic syndrome and multiple myeloma, there are still concerns about pro-thrombotic effects, especially when used with dexamethasone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: an immunomodulatory drug. Crane, E., List, A.[2018]

Lenalidomide has shown significant efficacy in improving survival rates for patients with relapsed and refractory myeloma, especially when used alongside other treatments like bortezomib and thalidomide.

While lenalidomide is effective, it is associated with common side effects such as fatigue and thrombocytopenia, and its combination with other agents can increase the risk of blood clots, highlighting the importance of managing these adverse events for continued treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide for the treatment of relapsed and refractory multiple myeloma. van de Donk, NW., Görgün, G., Groen, RW., et al.[2021]

Lenalidomide has become a crucial treatment option for multiple myeloma and del-5q myelodysplastic syndromes, and it has been tested for various other cancers, showcasing its broad therapeutic potential.

The drug received FDA approval for use in combination with dexamethasone for previously treated multiple myeloma, highlighting its efficacy and safety in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a novel anticancer drug with multiple modalities. Galustian, C., Dalgleish, A.[2019]

Citations

1.

pubmed.ncbi.nlm.nih.gov

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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.

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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).

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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 ...

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bmccancer.biomedcentral.com

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

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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 ...

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pmc.ncbi.nlm.nih.gov

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

Long‐term survival and safety of elranatamab in patients with ...

Elranatamab monotherapy continues to improve survival outcomes without new safety signals. ... multiple myeloma: phase 2 MagnetisMM‐3 trial results. Nat Med. 2023 ...

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.

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 ...

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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 ...