What is the mechanism of action of this treatment?

Common treatments for Multiple Myeloma include bispecific antibodies like Cevostamab, which target BCMA on myeloma cells and CD3 on T cells, facilitating the immune system's ability to attack cancer cells. CAR T-cell therapies also target BCMA, modifying a patient's T cells to better recognize and destroy myeloma cells. These therapies are significant because they offer targeted approaches that can lead to deep and durable responses, especially in relapsed or refractory cases where traditional treatments may fail. By harnessing the body's immune system, these treatments provide new hope for improved outcomes in Multiple Myeloma patients.

What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including monoclonal antibodies like daratumumab and combination therapies, often have side effects such as neutropenia, lymphocytopenia, and increased risk of infections, including pneumonia and viral reactivations (e.g., herpes zoster, CMV). Other side effects can include fatigue, nausea, and peripheral neuropathy, as seen with carfilzomib. Additionally, treatments like lenalidomide and dexamethasone can cause upper respiratory tract infections, hypokalemia, muscle spasms, and hypertension. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including monoclonal antibodies and bispecific antibodies. Daratumumab, an anti-CD38 monoclonal antibody, has been approved for use in combination with other drugs like bortezomib and dexamethasone. Elotuzumab, targeting SLAMF7, is another monoclonal antibody approved for use with lenalidomide and dexamethasone. Bispecific antibodies like teclistamab, which targets BCMA and CD3, have shown promising results in clinical trials, similar to the investigational drug Cevostamab. These therapies aim to enhance the immune system's ability to target and destroy myeloma cells.

What other types of research exist?

Promising novel alternatives to Cevostamab for Multiple Myeloma patients include: 1) CAR T-cell therapies targeting BCMA, such as Idecabtagene Vicleucel and Ciltacabtagene Autoleucel, which have shown high response rates in clinical trials. 2) Bispecific antibodies like Teclistamab, which also targets BCMA and CD3, offering a similar mechanism of action to Cevostamab. 3) Antibody-drug conjugates such as Belantamab Mafodotin, which targets BCMA and delivers cytotoxic agents directly to myeloma cells. These therapies have demonstrated promising efficacy and safety profiles in recent studies.

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Monoclonal Antibodies

Cevostamab for Multiple Myeloma (CAMMA 1 Trial)

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies

For Cohort B1S: Participants with R/R MM who have received at least two prior lines of treatment

Must not have

Symptomatic active pulmonary disease or requiring supplemental oxygen

Inability to comply with protocol-mandated hospitalization and activities restrictions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called cevostamab alone and with other drugs to help patients with multiple myeloma that has come back or not responded to treatment. The drug aims to help the immune system kill cancer cells.

Who is the study for?

This trial is for adults with relapsed or refractory Multiple Myeloma who have tried other treatments without success or cannot tolerate them. Participants must be willing to provide bone marrow samples, use contraception, and have a life expectancy of at least 12 weeks. They should not have had certain recent treatments, autoimmune diseases, major surgery, severe heart conditions, or specific allergies.

What is being tested?

The study tests Cevostamab alone or combined with Pomalidomide and Dexamethasone (Pd) or Daratumumab and Dexamethasone (Dd). It's an open-label Phase Ib trial where participants receive these drugs through IV infusion to assess safety, tolerability, how the body processes the drug (PK), and how it works in the body (PD).

What are the potential side effects?

Potential side effects include reactions related to infusions such as fever or chills; blood disorders; increased risk of infections; fatigue; allergic reactions; potential impact on organ functions like liver or kidneys. Specific side effects will depend on which treatment combination is received.

Eligibility Criteria

Inclusion Criteria

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

Select...

My multiple myeloma has returned or is resistant, and I can't tolerate or use standard treatments.

Select...

I have relapsed or refractory multiple myeloma and have undergone at least two prior treatments.

Select...

I have relapsed or refractory multiple myeloma and have undergone at least two prior treatments.

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I agree to give samples for a bone marrow biopsy and aspirate.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I need extra oxygen or have trouble breathing due to lung problems.

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I can follow the study's required hospital stays and activity limits.

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I have had a stem cell transplant from a donor.

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I haven't had cancer treatments like monoclonal antibodies in the last 4 weeks.

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I have not had CAR T-cell therapy in the last 12 weeks.

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I have had a solid organ transplant.

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I have not had any other cancer in the last 2 years.

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I have had side effects from previous immunotherapy.

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I have been diagnosed with amyloidosis.

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I cannot tolerate blood clot prevention treatments.

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I am allergic to certain biopharmaceuticals or components in daratumumab.

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I have a serious heart condition.

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I have or might have a long-term active Epstein-Barr virus infection.

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I haven't had any radiation treatment in the last month.

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I do not have serious heart conditions like recent heart attacks or uncontrolled heart rhythm problems.

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I have had severe reactions to previous immune therapies.

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I have tested positive for HIV.

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I had a stem cell transplant using my own cells within the last 100 days.

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I currently have an active infection.

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I have COPD with less than half the normal lung function.

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I haven't had immunotherapy treatments in the last 12 weeks or 5 half-lives of the drug.

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I have been diagnosed with progressive multifocal leukoencephalopathy.

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I've had severe skin reactions or allergies to specific cancer drugs before.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have previously been treated with cevostamab or a similar drug.

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I am not pregnant or breastfeeding and do not plan to become pregnant soon.

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I haven't taken any cancer drugs in the last 4 weeks or within 5 half-lives of the drug.

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My cancer is near vital organs and could worsen quickly.

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I have had a brain-related condition like stroke or epilepsy.

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I have a history of HLH or MAS.

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I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.

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I have hepatitis C.

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I do not have active COVID-19 or have recovered with two negative tests 24 hours apart.

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

3Treatment groups

Experimental Treatment

Group I: Single-Agent Cevostamab (Arm A)Experimental Treatment3 Interventions

Cohort A1S is a safety run-in arm evaluating cevostamab administered in 28-day cycles on a modified weekly schedule. Cohort A1E, an expansion cohort, has been opened and finished enrolling participants. Participants will be treated with single-agent cevostamab administered in 28-day cycles on a modified weekly schedule.

Group II: Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)Experimental Treatment4 Interventions

Participants will be treated with cevostamab monotherapy during a 14-day period prior to the start of pomalidomide treatment (cevostamab pre-phase). Cohort B1S is a safety run-in arm evaluating cevostamab and Pd administered in 28-day cycles every 2 weeks (Q2W) followed by every 4 weeks (Q4W) schedule. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of target dose level 1 (DL1) and lower dose level -1 (DL-1) of cevostamab will be selected for randomization in expansion cohorts. Expansion cohorts will follow the same Q2W/Q4W dosing schedule as Cohort B1S.

Group III: Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)Experimental Treatment4 Interventions

Cohort C1S is a safety run-in arm evaluating cevostamab and Dd administered in 21 day cycles from Cycle(C)1 - C8 every 3 weeks (Q3W) and 28-day cycles from C9 onwards Q4W. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of DL1 and DL-1 of cevostamab will be selected for randomization in expansion cohorts. Expansion cohorts will follow the same Q3W/Q4W dosing schedule as Cohort C1S.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Tocilizumab

2012

Completed Phase 4

~1840

Pomalidomide

2011

Completed Phase 2

~1020

Daratumumab

2014

Completed Phase 3

~2000

0 / 38Eligibility 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

Common treatments for Multiple Myeloma include bispecific antibodies like Cevostamab, which target BCMA on myeloma cells and CD3 on T cells, facilitating the immune system's ability to attack cancer cells. CAR T-cell therapies also target BCMA, modifying a patient's T cells to better recognize and destroy myeloma cells. These therapies are significant because they offer targeted approaches that can lead to deep and durable responses, especially in relapsed or refractory cases where traditional treatments may fail. By harnessing the body's immune system, these treatments provide new hope for improved outcomes in Multiple Myeloma patients.

Chimeric antigen receptor T cell targeting B cell maturation antigen immunotherapy is promising for multiple myeloma.Anti-BCMA CAR T-cell therapy in multiple myeloma: can we do better?