Elranatamab for Multiple Myeloma

Overseen By Qaiser Bashir, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antipsychotics, Statins, Benzodiazepines, others

Disqualifiers: HIV, Hepatitis B/C, Cardiovascular, 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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a medication called elranatamab, alongside a stem cell transplant, can help control multiple myeloma in patients recently diagnosed with a high-risk form of the disease. The process involves several steps: reducing cancer cells, collecting and transplanting the patient's own stem cells, and maintaining disease control with ongoing therapy. Patients diagnosed with high-risk multiple myeloma who have responded positively to initial treatment may be good candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it advises caution with certain drugs that interact with the CYP enzyme system, like warfarin and statins. You should discuss your current medications with the trial team to ensure safety.

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

Research shows that elranatamab is generally safe for people with multiple myeloma. In past studies, many patients handled the treatment well. For instance, one study found that about 26% of patients had a complete response, with no cancer detected in their blood or urine after treatment. Another study reported a 75% overall response rate for elranatamab, with 30% of patients experiencing a complete or nearly complete response. These findings suggest that while side effects may occur, they are usually manageable for many patients.

Elranatamab is currently being tested in a Phase 2 study, so its safety and effectiveness are still under careful evaluation. However, earlier research has provided helpful information about its safety, showing that many patients tolerate it well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Elranatamab is unique because it offers a novel approach to treating multiple myeloma by specifically targeting and engaging BCMA (B-cell maturation antigen) on the surface of myeloma cells, which is different from the standard chemotherapy and immunomodulatory drugs used today. This targeted action could potentially lead to more effective destruction of cancer cells with fewer side effects. Additionally, the integration of elranatamab with stem cell transplantation aims to maximize the reduction of myeloma cells and improve long-term outcomes, which is an exciting advancement over traditional treatments. Researchers are optimistic that this combined approach could offer a more precise and durable response for patients battling this challenging condition.

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

Research has shown that elranatamab holds promise for treating multiple myeloma, a type of blood cancer. In this trial, participants will receive elranatamab as part of a comprehensive treatment plan, including induction therapy, purging, stem cell mobilization, conditioning therapy, an autologous stem cell transplant, and maintenance therapy. Studies have found that patients whose multiple myeloma returned or didn't respond to other treatments experienced significant and lasting improvements with elranatamab. In one study, 26% of patients achieved a complete response, with no cancer detected in their blood or urine. Another study demonstrated that patients treated with elranatamab had better outcomes compared to those receiving standard treatments. The overall response rate was 61%, and patients went an average of 17.2 months without disease progression. These findings suggest that elranatamab could be an effective option for managing multiple myeloma. ^{1 5 6 7 8}

Who Is on the Research Team?

Qaiser Bashir

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with newly diagnosed, high-risk multiple myeloma (MM), a type of blood cancer. Participants should be eligible for an autologous stem cell transplant, where their own stem cells are collected and returned to them after treatment.

Inclusion Criteria

Estimated creatinine clearance ≥40 mL/min

My cancer responded well to the initial treatment.

My liver is functioning well, within the required limits.

Exclusion Criteria

I do not have any serious mental health issues or unstable medical conditions.

I do not have active kidney, liver, lung diseases, bleeding, infections, or heart risks.

My condition worsened before starting maintenance therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Induction therapy is given to decrease the number of MM cells in the bone marrow

4-6 weeks

Purging

Purging is done to remove leftover MM cells after induction therapy

2 weeks

Stem Cell Mobilization

Stem cell mobilization is done to move stem cells from the bone marrow into the blood for collection

1-2 weeks

Conditioning Therapy

Conditioning therapy is given to prepare the body to receive the stem cell transplant

1 week

Autologous Stem Cell Transplant

Participants undergo an autologous stem cell transplant

1 week

Maintenance Therapy

Maintenance therapy is given to help control the disease after the stem cell transplant

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Elranatamab
• Stem cell transplant

Trial Overview The study tests if elranatamab given before and after a person's own stem cell transplant can control high-risk MM better. Other drugs like Plerixafor, G-CSF, Busulfan, Lenalidomide, Melphalan may also be used in the process.

How Is the Trial Designed?

Group I: Elranatamab Experimental Treatment 7 Interventions

1. Induction therapy - This is given to decrease the number of MM cells in the bone marrow. 2. Purging - This is done to remove leftover MM cells after induction therapy. 3. Stem cell mobilization - This is done to move stem cells from your bone marrow into the blood, so they can be collected for the autologous stem cell transplant. 4. Conditioning therapy - This is given to help prepare the body to receive the stem cell transplant. 5. Autologous stem cell transplant 6. Maintenance therapy - This is given to help control the disease after the stem cell transplant.

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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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

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]

High-dose melfalan chemotherapy followed by autologous blood stem cell transplantation significantly increases the chances of achieving complete remission and extends survival in patients with multiple myeloma compared to traditional chemotherapy.

Recent studies suggest that patients with multiple myeloma and renal insufficiency can also benefit from stem cell transplantation, as demonstrated by the first successful case reported in this study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autologous transplantation of peripheral hematopoietic cells in a patient with multiple myeloma and renal insufficiency]. Krejcí, M., Doubek, M., Adam, Z., et al.[2013]

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 2 study involving 46 patients with newly diagnosed multiple myeloma, the quadruplet regimen of elotuzumab, carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) achieved a stringent complete response (sCR) and/or measurable residual disease (MRD)-negativity rate of 58% after 8 cycles, indicating significant efficacy without the need for autologous stem cell transplant (ASCT).

The study demonstrated a 3-year progression-free survival (PFS) rate of 72% overall, and an impressive 92% for patients who achieved MRD-negativity, suggesting that MRD-guided therapy could allow for reduced treatment exposure while maintaining effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab and Weekly Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Without Transplant Intent: A Phase 2 Measurable Residual Disease-Adapted Study. Derman, BA., Kansagra, A., Zonder, J., et al.[2023]

Recent advancements in myeloma treatment include new proteasome inhibitors like carfilzomib and ixazomib, immune-modulatory drugs such as pomalidomide, and monoclonal antibodies like elotuzimab and daratumumab, which have significantly changed the treatment landscape for this disease.

The chapter offers a case-based approach to managing myeloma therapy in transplant-eligible patients, reflecting the latest treatment options available as of 2018.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case-based roundtable on treatment approach for young, fit, newly diagnosed multiple myeloma patients. Giralt, S., Seifter, E.[2020]

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 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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454520/

Elranatamab Fixed Dosing: A Safe, Effective, and Convenient ... The primary efficacy and safety results of the MagnetisMM-3 trial were previously reported [16]. The primary end point was confirmed by ...

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. 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 ...