Elranatamab for Multiple Myeloma

Overseen By Tyler rampersaud

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Anti-cancer agents

Disqualifiers: Active infection, Plasma cell leukemia, CNS involvement, Guillain-Barre, Uncontrolled medical problems, 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

Duration: 12 months

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Elranatamab as a follow-up treatment for individuals with high-risk multiple myeloma, a type of blood cancer. The primary goal is to determine how long patients can live without their cancer worsening after initial treatment with cilta-cel. It targets those whose myeloma grows outside the bones or have specific genetic risks and have already tried at least two other treatments. Participants should have completed cilta-cel treatment 3-6 months prior and not show signs of disease progression. As a Phase 2 trial, this study focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you cannot use other anti-cancer agents or treatments while participating.

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

Research has shown that elranatamab, the treatment under study, is generally safe for people with multiple myeloma, a type of blood cancer. Studies have found that it leads to strong and lasting improvements in patients, with side effects that are usually mild and manageable with proper care. Previous research suggests that switching to a biweekly dosing schedule might enhance its long-term safety. Overall, elranatamab appears well-tolerated, offering hope for those with relapsed or hard-to-treat multiple myeloma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Elranatamab is unique because it offers a new approach to maintaining remission in multiple myeloma patients, especially those at high risk. Unlike traditional treatments like proteasome inhibitors or immunomodulatory drugs, Elranatamab is a bispecific antibody that targets both the BCMA protein on myeloma cells and CD3 on T-cells, effectively redirecting the immune system to attack the cancer cells. This dual-targeting mechanism could lead to more effective and sustained disease control. Researchers are excited about Elranatamab because it represents a promising advance in immunotherapy, with the potential to improve outcomes for patients who have already undergone other treatments.

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

Research has shown that Elranatamab yields promising results for patients with relapsed or hard-to-treat multiple myeloma. In one study, patients experienced an average of 17.2 months without disease progression, living over a year without worsening symptoms. Another study found that patients lived an average of 24.6 months, suggesting Elranatamab may extend survival. In this trial, Elranatamab will serve as maintenance therapy for patients with high-risk multiple myeloma who have received cilta-cel without evidence of disease progression. These findings suggest that Elranatamab could be an effective ongoing treatment for high-risk multiple myeloma following initial therapy. ^{3 4 6 7 8}

Who Is on the Research Team?

Melissa Alsina, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with high-risk relapsed myeloma who have previously received cilta-cel and other treatments, including immunomodulatory drugs, proteasome inhibitors, and CD38 monoclonal antibodies. They must be in good enough health to participate in the study schedule, have adequate liver function and bone marrow function, and not be pregnant or breastfeeding. Those with severe kidney issues requiring dialysis or certain medical conditions like Guillain-Barre syndrome cannot join.

Inclusion Criteria

Understand and voluntarily sign an informed consent form

I have a ClonoSEQ ID for tracking my minimal residual disease status.

Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

I am on dialysis for kidney failure.

Patients with history of Guillain-Barre syndrome

I am currently experiencing side effects from cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Elranatamab as maintenance therapy for a total of 12 months starting 3-6 months post cilta-cel infusion

12 months

Follow-up

Participants are monitored for progression-free survival and other outcomes after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Elranatamab

Trial Overview

The trial is testing Elranatamab's effectiveness following cilta-cel therapy in patients with high-risk relapsed myeloma. It aims to see how long these patients can live without their myeloma worsening after this treatment sequence. The focus is on those less responsive to cilta-cel due to specific risk factors such as extramedullary disease or particular genetic mutations.

How Is the Trial Designed?

Group I: Elranatamab Maintenance Therapy Experimental Treatment 1 Intervention

Patients who have received cilta-cel without evidence of disease progression and have clinical high-risk myeloma, will be treated with Elranatamab as maintenance therapy for a total of 12 months starting 3-6 months post cilta-cel infusion, at the FDA approved full dose.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

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, 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]

Elotuzumab is an FDA-approved monoclonal antibody for multiple myeloma that targets SLAMF7, a protein found on myeloma and natural killer cells, enhancing the immune response against cancer cells.

In clinical trials, elotuzumab showed strong efficacy and a good safety profile when used with other treatments like immunomodulatory drugs and proteasome inhibitors, making it a promising option for multiple myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab for the treatment of multiple myeloma. Wang, Y., Sanchez, L., Siegel, DS., et al.[2022]

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]

Elotuzumab, when combined with other treatments, significantly improved progression-free survival (PFS) by 14% and overall survival (OS) by 20% in multiple myeloma patients, based on a review of five randomized control trials involving 1,763 participants.

While Elotuzumab showed efficacy in relapsed/refractory multiple myeloma, it also increased the risk of serious adverse events, infections, and cardiac disorders, indicating a need for careful monitoring in patients receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Elotuzumab combination therapy for patients with multiple myeloma: A systematic review and meta-analysis. Noori, M., Fayyaz, F., Rezaei, N.[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]

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