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

Trial Summary

What is the purpose of this trial?

To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.

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.

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

Elranatamab has shown promising results in clinical trials for multiple myeloma, with a significant number of patients responding to the treatment and achieving complete responses. In the MagnetisMM-1 trial, 63.6% of patients responded to the drug, and the median duration of response was 17.1 months, indicating its potential effectiveness in managing this condition. ^{1 2 3 4 5}

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 immune system to attack the cancer cells. It is administered subcutaneously (under the skin) and has shown promising results in patients who have already tried multiple other treatments. ^{1 2 3 6 7}

Research Team

Qaiser Bashir

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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]

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]

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]

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]

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

Elrexfio™ (elranatamab-bcmm): The game-changer in treatment of multiple myeloma. [2023]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[Autologous transplantation of peripheral hematopoietic cells in a patient with multiple myeloma and renal insufficiency]. [2013]

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

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

6. United States 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. [2023]

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

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