Elranatamab for Multiple Myeloma

Recruiting at 287 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must be taking: Anti-CD38, Lenalidomide

Must not be taking: BCMA therapy, CD3 therapy

Disqualifiers: Smoldering MM, 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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 5 years

492 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new medication, elranatamab, for treating multiple myeloma, a type of blood cancer. The goal is to evaluate elranatamab's effectiveness compared to other standard treatments. Individuals who have previously received treatment for multiple myeloma, but whose disease has returned or not responded to their last treatment, might be suitable candidates. Participants will receive either elranatamab or a combination of other medications selected by the study doctor. The study aims to determine the safety and effectiveness of elranatamab in managing multiple myeloma. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the study doctor to understand how your current treatments might interact with the trial.

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

Research has shown that elranatamab is generally safe to use, with side effects that are usually not serious. In earlier studies, many patients tolerated the treatment well. For instance, one study found that elranatamab did not cause any new or unexpected safety issues over time.

The treatment has shown promising results for people with multiple myeloma, a type of cancer. It's important to remember that all medicines can have side effects, which can differ from person to person. However, overall evidence suggests that patients generally tolerate elranatamab well. Those considering joining a trial should discuss possible side effects with their doctor to understand what to expect. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Elranatamab is unique because it's a bispecific antibody that targets both BCMA, a protein commonly found on multiple myeloma cells, and CD3 on T cells. This dual-targeting mechanism is different from standard treatments like lenalidomide or bortezomib, which focus on different pathways. Researchers are excited because Elranatamab may activate the immune system to attack myeloma cells more directly, potentially leading to more effective treatments with fewer side effects. This novel approach offers hope for better outcomes in patients with multiple myeloma.

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

Research has shown that elranatamab, which participants in this trial may receive as monotherapy, may benefit people with multiple myeloma, a type of blood cancer. In earlier studies, patients whose cancer returned or did not respond to other treatments experienced strong and lasting improvements with elranatamab. Specifically, about 26% of these patients achieved a complete response, with no cancer detected in their blood or urine after treatment. Additionally, 61% of patients saw a reduction in their cancer. These results suggest that elranatamab could be a promising option for those with difficult-to-treat multiple myeloma. ^{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 adults with Multiple Myeloma (MM) that has returned or hasn't responded after treatment, including anti-CD38 antibody and lenalidomide. Participants must have had 1 to 4 prior MM treatments, meet specific lab value criteria, not be pregnant or breastfeeding, and agree to use contraception.

Inclusion Criteria

You are not pregnant or breastfeeding and are okay with using birth control.

My last cancer treatment did not work according to IMWG standards.

My last cancer treatment did not work as expected.

Exclusion Criteria

I do not have any ongoing serious infections.

I haven't had any cancer except for certain skin cancers or localized cancers that were treated, in the last 3 years.

I cannot undergo the standard treatment recommended by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elranatamab or a combination therapy until their MM is no longer responding

Up to approximately 5 years

Weekly visits initially, with potential reduction in frequency

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 35 days after last administration of study intervention

Telephone contacts or visits

What Are the Treatments Tested in This Trial?

Interventions

• Elranatamab

Trial Overview The study compares elranatamab—a new medication given as a weekly shot—with a combination of standard MM therapies chosen by the doctor. The goal is to evaluate elranatamab's safety and effectiveness against these common treatments.

How Is the Trial Designed?

Group I: Elranatamab Experimental Treatment 1 Intervention

Participants will receive elranatamab monotherapy

Group II: Investigator's Choice Active Control 5 Interventions

Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)

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

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 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]

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]

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 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 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]

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]

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]

Citations

1. 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. 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 ...

4. 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 ...

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. 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 ...

7. 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 ...

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 ...

9. 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 ...