What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving bispecific antibodies like Cevostamab, often lead to side effects such as neutropenia, infections, and pneumonia. Other monoclonal antibodies, such as daratumumab and elotuzumab, are associated with higher rates of lymphocytopenia, neutropenia, and viral reactivations like herpes zoster. Proteasome inhibitors and immunomodulatory drugs, frequently used in combination therapies, can cause cytopenias, gastrointestinal distress, and peripheral neuropathy. Overall, the risk of severe infections and hematologic toxicities is significant across these treatment modalities.

What prior FDA approvals exist?

Several FDA-approved treatments for Multiple Myeloma target BCMA, similar to Cevostamab. One notable example is the approval of idecabtagene vicleucel (Abecma), a BCMA-directed CAR-T cell therapy. Another is teclistamab, a bispecific antibody targeting BCMA and CD3, which has shown high efficacy in clinical trials. Additionally, belantamab mafodotin (Blenrep) is an antibody-drug conjugate targeting BCMA. These treatments represent significant advancements in targeting BCMA to treat relapsed or refractory Multiple Myeloma.

What other types of research exist?

Promising novel alternatives to Cevostamab for Multiple Myeloma patients include: <ol> <li>Daratumumab: An anti-CD38 monoclonal antibody, which has shown efficacy in both newly diagnosed and relapsed/refractory MM patients.</li> <li>Elotuzumab: Another monoclonal antibody targeting SLAMF7, used in combination with lenalidomide and dexamethasone.</li> <li>Isatuximab: An anti-CD38 monoclonal antibody, often combined with pomalidomide and dexamethasone.</li> <li>Ibrutinib: A BTK inhibitor, used in combination with other agents for relapsed/refractory MM.</li> <li>Venetoclax: A BCL-2 inhibitor, particularly effective in patients with t(11;14) translocation.</li> <li>Bispecific T-cell engagers (BiTEs): Other bispecific antibodies targeting BCMA, such as AMG 420 and AMG 701, are in development and show promise in clinical trials.</li> </ol>

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Monoclonal Antibodies

Cevostamab for Multiple Myeloma (CAMMA 2 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a medication called cevostamab for patients whose multiple myeloma has returned or not responded to other treatments. It works by helping the immune system target and destroy cancer cells.

Who is the study for?

This trial is for adults with relapsed/refractory multiple myeloma who have previously been treated with BCMA-targeted therapies and are triple-class refractory. They should expect to live at least 12 weeks, be able to perform daily activities (ECOG status of 0 or 1), and agree to use contraception if necessary. People can't join if they've had certain medical conditions, recent drug abuse, severe allergies to monoclonal antibodies, or are pregnant.

What is being tested?

The study tests the effectiveness and safety of a drug called Cevostamab given through IV infusion in patients whose multiple myeloma has not responded to previous treatments. It also looks at how the body processes the drug. Tocilizumab may be used as part of treatment management.

What are the potential side effects?

Possible side effects include allergic reactions related to infusion, increased risk of infections due to immune system suppression, potential liver issues indicated by hepatitis B reactivation, and other common chemotherapy-related side effects like fatigue and nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort B2: Prior BCMA BispecificExperimental Treatment2 Interventions

Expansion Cohort B2 will be opened, after the initial results from Cohort A2, at the same dose as per Cohort B1.

Group II: Cohort B1: Prior BCMA CAR-TExperimental Treatment2 Interventions

Participants enrolled in expansion Cohort B1, will be given cevostamab at the selected dosing regimen.

Group III: Cohort A2: Prior BCMA BispecificExperimental Treatment2 Interventions

Participants enrolled into exploratory Cohort A2 will receive the same dosing regimen as Cohort A1.

Group IV: Cohort A1: Prior BCMA antibody-drug conjugate (ADC) or chimeric antigen receptor T (CAR-T)Experimental Treatment2 Interventions

Participants in Cohort A1 will be treated at the double step-up split dosing regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Do I qualify?Apply below to find out

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 target specific proteins on myeloma cells or modulate the immune system to attack these cells. Cevostamab, a bispecific antibody, targets BCMA (B cell maturation antigen) on myeloma cells and CD3 on T cells, effectively redirecting T cells to kill the myeloma cells. This mechanism is crucial as it harnesses the body's immune system to specifically target and eliminate cancer cells. Other common treatments include proteasome inhibitors (e.g., bortezomib), which disrupt protein degradation in myeloma cells leading to cell death, and immunomodulatory drugs (e.g., lenalidomide), which enhance the immune response against myeloma cells. Monoclonal antibodies (e.g., daratumumab) target specific antigens on myeloma cells to induce cell death. These treatments are vital for managing Multiple Myeloma as they offer targeted approaches to reduce tumor burden and improve patient outcomes.

Chimeric antigen receptor T cell targeting B cell maturation antigen immunotherapy is promising for multiple myeloma.