What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving bispecific antibodies like Cevostamab, often result in significant side effects. These include high rates of neutropenia, infections (bacterial, viral, and fungal), and pneumonia. For instance, teclistamab, another bispecific antibody, has shown high rates of grade ≥3 neutropenia (64.2%), infections (44.8%), and pneumonia (12.7%). Other monoclonal antibodies such as daratumumab and elotuzumab are associated with increased risks of lymphocytopenia, opportunistic infections, and infusion reactions. Patients undergoing these treatments should be closely monitored for these adverse effects.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for Multiple Myeloma, including bispecific antibodies and monoclonal antibodies. Notably, teclistamab, a bispecific T cell engager (BiTE) targeting BCMA on myeloma cells and CD3 on T cells, has shown promising results. Other approved monoclonal antibodies include daratumumab and isatuximab, both targeting CD38 on myeloma cells. These therapies aim to enhance the immune system's ability to target and destroy myeloma cells, similar to the mechanism of action being studied with Cevostamab.

What other types of research exist?

Promising novel alternatives to Cevostamab for Multiple Myeloma patients in 2024 include: 1) Teclistamab, a bispecific antibody targeting BCMA and CD3, 2) Idecabtagene vicleucel (ide-cel) and Ciltacabtagene autoleucel (cilta-cel), both BCMA-directed CAR T-cell therapies, and 3) Isatuximab, an anti-CD38 monoclonal antibody. These therapies have shown significant efficacy in clinical trials for relapsed/refractory MM.

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Cevostamab Following CAR T Cell Therapy for Multiple Myeloma

Phase 2

Recruiting

Led By Adam D Cohen, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months post-car t cell therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Cevostamab, an IV medication given periodically, in patients with myeloma that has returned or not responded to treatment. These patients have already received a special cell therapy and are recovering from it. The goal is to see if Cevostamab can help their immune system better fight the cancer.

Who is the study for?

This trial is for adults over 18 with relapsed/refractory multiple myeloma who've had at least four prior treatments, including a proteasome inhibitor, IMiD, and anti-CD38 antibody. They must have undergone BCMA-directed CAR T cell therapy recently without disease progression and be able to follow the study plan.

What is being tested?

The study tests Cevostamab given intravenously every three weeks starting about ten weeks after CAR T cell therapy. The goal is to see if it improves complete remission rates at 12 months post-CAR T treatment in patients with multiple myeloma.

What are the potential side effects?

Potential side effects of Cevostamab are not detailed here but may include reactions similar to other monoclonal antibodies such as infusion-related reactions, immune system complications, or organ inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months post-car t cell therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months post-car t cell therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months post-car t cell therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

MRD-negative complete remission (CR)

Secondary study objectives

Feasibility of cevostamab administration post-BCMA CAR T cell therapy

Impact of cevostamab consolidation post-BCMA CAR T cell therapy on other clinical outcomes

Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) of cevostamab administration post-BCMA CAR T cell therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CevostamabExperimental Treatment1 Intervention

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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

Multiple Myeloma treatments often involve immunotherapies that target specific antigens on myeloma cells and engage the immune system to destroy these cells. Bispecific antibodies, like Cevostamab, target both CD3 on T cells and specific antigens on myeloma cells (e.g., FcRH5), effectively redirecting T cells to kill the cancer cells. This mechanism is crucial as it leverages the body's immune system to fight the cancer more effectively. Other common treatments include proteasome inhibitors, which disrupt protein degradation in myeloma cells, and immunomodulatory drugs that enhance the immune response against myeloma cells. These therapies are vital for Multiple Myeloma patients as they offer targeted approaches to control and potentially eradicate the disease, improving survival rates and quality of life.

Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma.Myeloma: next generation immunotherapy.