Elranatamab for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Michael Slade, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Investigational agents, BCMA-based treatments

Disqualifiers: Other malignancy, CNS involvement, 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: 9

Duration: 12 months

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests elranatamab, a type of immunotherapy, as a personalized maintenance treatment for individuals with newly diagnosed multiple myeloma, a type of blood cancer. The goal is to evaluate the effectiveness of this treatment when guided by special blood tests that detect leftover cancer cells after a stem cell transplant. Participants will receive elranatamab for at least a year and undergo regular blood and bone marrow tests to monitor progress. This trial may suit those who have undergone a stem cell transplant for multiple myeloma and show signs of remaining cancer cells on specific tests. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that elranatamab has been tested in patients with multiple myeloma, a type of blood cancer. Earlier studies found elranatamab effective in treating this condition. However, some side effects have been reported. One serious side effect is cytokine release syndrome (CRS), which occurs when the body has a strong reaction to the treatment. This can be life-threatening or even fatal.

The FDA has approved elranatamab for adults with multiple myeloma who have tried several other treatments without success. This approval indicates that, despite the risks, its safety is considered acceptable for certain patients. Those considering joining a clinical trial for elranatamab should be aware of these risks and discuss them with their healthcare provider. ^{1 2 3 4 5}

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

Elranatamab is unique because it targets BCMA, a protein found on the surface of multiple myeloma cells, using a bispecific antibody approach. This means it can engage both the cancer cells and the body’s immune system simultaneously, potentially leading to more effective elimination of the cancer. Unlike traditional treatments like chemotherapy or proteasome inhibitors, which often attack rapidly dividing cells in general, Elranatamab specifically hones in on these cancer cells, which might reduce side effects. Researchers are excited about Elranatamab because it represents a targeted therapy that could offer a more precise and potentially less toxic treatment option for patients with multiple myeloma.

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 treating multiple myeloma, a type of blood cancer. In studies with patients whose cancer returned or didn't respond to other treatments, elranatamab helped 61% of them, meaning more than half saw their cancer improve. Specifically, 26% of patients achieved complete remission, with no cancer found in their blood or urine. These results suggest that elranatamab can provide strong and lasting benefits for many patients. Overall, this evidence highlights elranatamab's potential as an effective treatment option for multiple myeloma. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Slade, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for newly diagnosed multiple myeloma patients who have undergone a stem cell transplant. It's designed to see if monitoring their blood with a special test (EasyM assay) and treating them with elranatamab can help keep the cancer in check.

Inclusion Criteria

I am 80-140 days post-transplant with myeloma still detectable.

I had a stem cell transplant for my IgG or IgA multiple myeloma.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

Presence of light chain or non-secretory disease

I have previously received BCMA-targeted therapy.

I do not have any ongoing serious illnesses like leukemia, POEMS syndrome, or uncontrolled infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maintenance elranatamab therapy with MRD testing every 6 months

12 months

MRD testing every 6 months

Observation

Standard disease monitoring every 3 months and bone marrow-based MRD every 6 months until MRD recurrence or disease progression

Up to 36 months

Standard monitoring every 3 months, MRD testing every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Elranatamab

Trial Overview The study tests whether using the EasyM assay to monitor blood for cancer signs after a stem cell transplant, combined with maintenance therapy using elranatamab, is effective and tolerable for multiple myeloma patients.

How Is the Trial Designed?

Group I: Elranatamab Experimental Treatment 2 Interventions

Patients will receive at least 12 months of maintenance elranatamab therapy. Patients will have MRD testing within clonoSEQ every 6 months. If 2 consecutive tests are negative, elranatamab will be stopped and the patient will go on observation schedule. Once a patient starts the observation schedule, standard disease monitoring will be performed every 3 months and bone marrow-based MRD will be performed every 6 months until MRD recurrence, disease progression or end of study period (patients' on-study status will be a maximum of 36 months for treatment and intensive observation combined). Patients who experience MRD recurrence will be re-treated per study protocol. A patient may move back to the observation schedule after treatment re-initiation provided the same criteria as above are met (2 consecutive negative MRD tests). Patients who are determined to have progressive disease per IMWG criteria (whether on treatment or observation schedule) will transition off study.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Rapid Novor

Collaborator

Trials

1

Recruited

70+

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 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]

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 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]

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]

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]

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. 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 ...

3. 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 ...

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. 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 ...

6. elrexfio.com elrexfio.com/

ELREXFIO® (elranatamab-bcmm) Info for Patients Find information on FDA-approved ELREXFIO® (elranatamab-bcmm) monotherapy for certain adults with relapsed or refractory multiple myeloma. See Safety Info and

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/761345s004lbl.pdf

761345s004lbl.pdf - accessdata.fda.gov ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, ...

8. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/6737/506306/Safety-of-Elranatamab-in-Patients-with-Triple

Safety of Elranatamab in Patients with Triple-Class Refractory ... Elranatamab is an investigational BCMA-CD3 bispecific antibody for the treatment of patients with multiple myeloma.

9. elrexfio.pfizerpro.com elrexfio.pfizerpro.com/resources-and-support/materials

Materials - ELREXFIO - Pfizer Pro Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step- ...

10. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/elrexfio

Elrexfio | European Medicines Agency (EMA) Elrexfio was shown to be effective at clearing the cancer in an ongoing study. This study involved 123 patients with multiple myeloma whose ...