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Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

39 Participants Needed

Elranatamab for Multiple Myeloma

Overseen BySonila Toska

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 GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

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

Research shows that Elranatamab, a drug used for multiple myeloma, had a 63.6% response rate in patients who had previously tried other treatments, with many achieving complete response. It also showed promising survival rates, with a median progression-free survival of 11.8 months and overall survival of 21.2 months.¹ ² ³ ⁴ ⁵

How is the drug Elranatamab different from other treatments for 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 T cells to attack the cancer cells. It is administered subcutaneously and has shown promising results even in patients who have had multiple prior treatments, including those who have already received BCMA-directed therapies.¹ ² ³ ⁴ ⁶

What is the purpose of this trial?

The purpose of the study is to evaluate the effect of Elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (PFS). Patients with clinical high-risk myeloma, defined as having history of myeloma that has grown outside of the bones or having high risk mutations in the myeloma cells, benefit less from cilta-cel compared to myeloma patients without these characteristics.

Research Team

Melissa Alsina, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

See 6 more

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.

See 7 more

Timeline

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

Treatment Details

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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Elranatamab Maintenance TherapyExperimental Treatment1 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.

Find a Clinic Near You

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

Findings from Research

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]

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]