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Monoclonal Antibodies

Cevostamab for Multiple Myeloma (CAMMA 2 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T or ADC therapy and are triple-class relapsed or refractory
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

CAMMA 2 Trial Summary

This trial will study a new drug for people with a certain type of blood cancer who have not responded to other treatments.

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.Check my eligibility
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.See study design
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.

CAMMA 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had BCMA-targeted therapy and my cancer is resistant to three types of treatment.
Select...
I am fully active or can carry out light work.
Select...
My cancer has worsened after my last treatment.
Select...
I have been diagnosed with multiple myeloma according to IMWG standards.
Select...
I have had BCMA-targeting treatment and my cancer is resistant to three types of treatments.
Select...
I agree to not have unprotected sex or donate sperm for 2 months after my last dose of treatment.

CAMMA 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) as Determined by the Investigator
Percentage of Participants with Adverse Events
Secondary outcome measures
Cytokine Release Syndrome (CRS) Following Administration of Tocilizumab
Duration of Response (DOR)
Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline
+14 more
Other outcome measures
Minimal Residual Disease (MRD) Negative Rate

CAMMA 2 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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,089,061 Total Patients Enrolled
13 Trials studying Multiple Myeloma
2,395 Patients Enrolled for Multiple Myeloma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,501 Total Patients Enrolled
19 Trials studying Multiple Myeloma
3,118 Patients Enrolled for Multiple Myeloma

Media Library

Cevostamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05535244 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Cohort B1: Prior BCMA CAR-T, Cohort A1: Prior BCMA antibody-drug conjugate (ADC) or chimeric antigen receptor T (CAR-T), Cohort A2: Prior BCMA Bispecific, Cohort B2: Prior BCMA Bispecific
Multiple Myeloma Clinical Trial 2023: Cevostamab Highlights & Side Effects. Trial Name: NCT05535244 — Phase 1 & 2
Cevostamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05535244 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up to participate in this research project?

"According to the sponsor's website, a total of 140 patients that meet the clinical trial's inclusion criteria are needed. The sponsor, Hoffmann-La Roche, will be running the trial out of various sites including Memorial Sloan Kettering Cancer Center in New york, New York and Tennessee Onc., PLLC - SCRI in Nashville, Tennessee."

Answered by AI

Are new participants still being recruited for this clinical trial?

"That is correct. The information available on clinicaltrials.gov outlines that this research project, which was first publicized on 18th October 2022, is still recruiting participants. There are currently 3 recruitment sites active and the goal is to have 140 individuals enrolled in total."

Answered by AI
~59 spots leftby Feb 2027