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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cpp d1 up to approximately 4 years
Awards & highlights
CAMMA 1 Trial Summary
This trial will study the safety and effectiveness of cevostamab as a treatment for multiple myeloma.
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.Check my eligibility
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).See study design
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.
CAMMA 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I agree to give samples for a bone marrow biopsy and aspirate.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
CAMMA 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cpp d1 up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cpp d1 up to approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Dose Intensity
Percentage of Dose Interruptions
Percentage of Dose Reductions
+3 moreSecondary outcome measures
Clearance of Cevostamab
Complete Response/Stringent Complete Response (CR/sCR) Rate
Duration of Response (DOR)
+16 moreCAMMA 1 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
~2590
Tocilizumab
2012
Completed Phase 4
~1840
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,505 Total Patients Enrolled
23 Trials studying Multiple Myeloma
6,314 Patients Enrolled for Multiple Myeloma
Hoffmann-La RocheIndustry Sponsor
2,429 Previous Clinical Trials
1,089,218 Total Patients Enrolled
13 Trials studying Multiple Myeloma
2,301 Patients Enrolled for Multiple Myeloma
Clinical TrialsStudy DirectorGenentech, Inc.
2,199 Previous Clinical Trials
888,318 Total Patients Enrolled
19 Trials studying Multiple Myeloma
3,024 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant from a donor.My multiple myeloma has returned or is resistant, and I can't tolerate or use standard treatments.I haven't taken strong immune-suppressing drugs, except for low-dose steroids, in the last 2 weeks.I need extra oxygen or have trouble breathing due to lung problems.I can follow the study's required hospital stays and activity limits.I haven't had cancer treatments like monoclonal antibodies in the last 4 weeks.I have not had CAR T-cell therapy in the last 12 weeks.I have had a solid organ transplant.I have not had any other cancer in the last 2 years.You have a disease that can be measured or seen on tests or scans.I agree to use contraception or remain abstinent and not donate sperm or blood while on pomalidomide and for 4 weeks after.I agree to use birth control or remain abstinent during and for 102 days after my last daratumumab dose.I agree to use contraception or abstain from sex and not donate sperm for 102 days after my last daratumumab dose.You have too many plasma cells in your blood.You have a measurable amount of the Epstein-Barr virus (EBV) or Cytomegalovirus (CMV) in your blood before starting the study treatment.I have had side effects from previous immunotherapy.I have been diagnosed with amyloidosis.I cannot tolerate blood clot prevention treatments.I am allergic to certain biopharmaceuticals or components in daratumumab.I have a serious heart condition.I have relapsed or refractory multiple myeloma and have undergone at least two prior treatments.I have or might have a long-term active Epstein-Barr virus infection.I haven't had any radiation treatment in the last month.I do not have serious heart conditions like recent heart attacks or uncontrolled heart rhythm problems.I have had severe reactions to previous immune therapies.I have tested positive for HIV.I have not had major surgery in the last 4 weeks.I had a stem cell transplant using my own cells within the last 100 days.I agree to use contraception and not donate sperm for 2 months after my last dose.I have relapsed or refractory multiple myeloma and have undergone at least two prior treatments.I currently have an active infection.I have COPD with less than half the normal lung function.I agree to use two forms of birth control or remain abstinent while on pomalidomide treatment.You are expected to live for at least 3 months.I haven't had immunotherapy treatments in the last 12 weeks or 5 half-lives of the drug.You have had a disease where your body's immune system attacks itself.I have been diagnosed with progressive multifocal leukoencephalopathy.I've had severe skin reactions or allergies to specific cancer drugs before.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I agree to give samples for a bone marrow biopsy and aspirate.I have previously been treated with cevostamab or a similar drug.I am not pregnant or breastfeeding and do not plan to become pregnant soon.I haven't taken any cancer drugs in the last 4 weeks or within 5 half-lives of the drug.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have relapsed or refractory multiple myeloma and have undergone at least one treatment.My cancer is near vital organs and could worsen quickly.You have had serious allergic reactions to monoclonal antibody treatments in the past.I have had a brain-related condition like stroke or epilepsy.I am fully active or restricted in physically strenuous activity but can do light work.You have tested positive for hepatitis B virus (HBV) infection.I have a history of HLH or MAS.I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.I have a digestive condition that affects how my body absorbs pills.My side effects from previous cancer treatments are mild or gone.I have hepatitis C.I do not have active COVID-19 or have recovered with two negative tests 24 hours apart.I have relapsed or refractory multiple myeloma and have been treated at least once.
Research Study Groups:
This trial has the following groups:- Group 1: Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)
- Group 2: Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)
- Group 3: Single-Agent Cevostamab (Arm A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Cevostamab being utilized in any other research trials?
"Cevostamab was initially studied at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002, and since then has been the subject of 1375 finished clinical trials. Currently 688 medical experiments are active, with many situated in Atlanta Georgia."
Answered by AI
Is this medical research currently accepting participants?
"According to the trial's listing on clinicaltrials.gov, recruitment is still underway with a first posted date of July 26th 2021 and most recent update being November 14th 2022."
Answered by AI
How many participants have enrolled in this research project?
"Yes, according to clinicaltrials.gov this research is presently seeking volunteers. The trial was first made available on July 26th 2021 and the latest update was provided on November 14th 2022. This investigation requires 170 participants over 7 sites of recruitment."
Answered by AI
In what circumstances is Cevostamab commonly prescribed?
"Cevostamab has been found to be an effective intervention for ophthalmic conditions, such as branch retinal vein occlusion and macular edema. It is also used in the treatment of communicable diseases."
Answered by AI
How many healthcare facilities are engaged in the implementation of this experimental protocol?
"Currently, there are 7 different medical centres that have begun recruiting patients for this research. Such facilities include the Winship Cancer Institute in Atlanta and Levine Cancer Institute in Charlotte with an additional 5 locations. Additionally, University Health Network; Princess Margaret Hospital's Medical Oncology Department is located in Toronto."
Answered by AI
Has the FDA certified Cevostamab for clinical use?
"Due to the evidence surrounding Cevostamab's efficacy and safety being limited, our team scored its risk level at 1 on a scale of 1 - 3."
Answered by AI
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