What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving bispecific antibodies like Elranatamab, often lead to various side effects. Treatments such as daratumumab, elotuzumab, and isatuximab, which are monoclonal antibodies, frequently cause neutropenia, lymphocytopenia, and increased infection rates, including pneumonia and viral reactivations (e.g., herpes zoster, CMV). Specific to bispecific antibodies targeting BCMA and CD3, like teclistamab, side effects include higher rates of severe infections, including respiratory infections and neutropenia. These treatments can also lead to infusion reactions, fatigue, gastrointestinal issues, and peripheral neuropathy.

What prior FDA approvals exist?

Several FDA-approved treatments for Multiple Myeloma involve mechanisms similar to Elranatamab, which targets BCMA and CD3 to mediate T-cell cytotoxicity. Teclistamab is a bispecific monoclonal antibody that targets BCMA and CD3, recruiting T cells to kill BCMA-expressing myeloma cells. Additionally, belantamab mafodotin, an anti-BCMA antibody-drug conjugate, was approved for relapsed/refractory Multiple Myeloma but has been withdrawn from the U.S. market. Other notable FDA-approved treatments include CAR T-cell therapies like idecabtagene vicleucel and ciltacabtagene autoleucel, which also target BCMA to treat Multiple Myeloma.

What other types of research exist?

Promising, novel alternatives to Elranatamab for Multiple Myeloma patients include: <ol> <li>Daratumumab (Anti-CD38 monoclonal antibody) - Effective in both newly diagnosed and relapsed/refractory patients, though associated with higher infection rates.</li> <li></li> </ol> Isatuximab (Anti-CD38 monoclonal antibody) - Approved for relapsed/refractory Multiple Myeloma, showing efficacy in combination with other agents. 3. Belantamab Mafodotin (Antibody-drug conjugate targeting BCMA) - Offers a novel mechanism of action with demonstrated efficacy, though associated with ocular toxicity. 4. Bispecific T-cell Engagers (BiTEs) - Other bispecific antibodies targeting BCMA and CD3, similar to Elranatamab, are in development and may offer additional options.

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Bispecific Antibody

Elranatamab for Multiple Myeloma

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

Refractory to at least one IMiD

Must not have

Stem cell transplant within 12 weeks prior to enrollment

Amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

Awards & highlights

Summary

This trial is testing Elranatamab, a drug that helps the immune system target and kill cancer cells, in patients with a type of blood cancer that hasn't responded to other treatments. The drug works by connecting immune cells to cancer cells so they can be destroyed.

Who is the study for?

This trial is for adults with multiple myeloma who haven't responded to at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 antibody. Participants should have measurable disease, be in stable condition, not pregnant, willing to use contraception, and without other active cancers or serious infections. There are two groups: those who've had BCMA-targeted therapy before and those who haven't.

What is being tested?

The study tests Elranatamab as a single treatment for relapsed/refractory multiple myeloma. It's a bispecific antibody that directs the body's T-cells to attack the cancer cells by recognizing both T-cell markers (CD3) and myeloma cell markers (BCMA). The goal is to see if this targeted approach can help control the disease.

What are the potential side effects?

Potential side effects of Elranatamab may include symptoms related to immune system activation such as fever, fatigue, infusion reactions where the medication enters the body, possible damage to healthy cells leading to low blood counts or organ dysfunction. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple myeloma.

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My condition did not improve after treatment with an IMiD.

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My last treatment for myeloma did not work.

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My condition did not improve after treatment with an anti-CD38 antibody.

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

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I have not had previous treatments targeting BCMA.

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I have previously received BCMA-targeted therapy.

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My condition did not improve after using a protease inhibitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant less than 3 months ago.

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I have been diagnosed with amyloidosis.

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I do not have any active infections like HBV, HCV, HIV, or uncontrolled bacterial, fungal, or viral infections.

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My condition is smoldering multiple myeloma.

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I have active plasma cell leukemia.

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I have been diagnosed with POEMS syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria

Secondary study objectives

Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline

Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline

Complete Response Rate (CRR) as Per IMWG Criteria by BICR

+17 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Elranatamab (cohort B)Experimental Treatment1 Intervention

BCMA-CD3 bispecific antibody

Group II: Elranatamab (cohort A)Experimental Treatment1 Intervention

BCMA-CD3 bispecific antibody

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bispecific antibodies, such as Elranatamab, target CD3 on T-cells and BCMA on multiple myeloma cells, promoting T-cell-mediated cytotoxicity. This mechanism is significant as it enhances the immune system's ability to identify and kill cancer cells. Other common treatments include proteasome inhibitors, which disrupt protein degradation in cancer cells, leading to cell death, and immunomodulatory drugs, which boost the immune response and inhibit cancer cell proliferation. These targeted therapies are crucial for multiple myeloma patients as they provide effective strategies to control and potentially eliminate the disease.

The evolving status of immunotherapies in multiple myeloma: the future role of bispecific antibodies.