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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
Study Summary
This trial will study how cevostamab may improve outcomes for people with relapsed/refractory myeloma who are receiving CAR T cell therapy.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MRD-negative complete remission (CR)
Secondary outcome measures
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: CevostamabExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,257 Total Patients Enrolled
13 Trials studying Multiple Myeloma
349 Patients Enrolled for Multiple Myeloma
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,113 Total Patients Enrolled
23 Trials studying Multiple Myeloma
6,468 Patients Enrolled for Multiple Myeloma
Adam D Cohen, MDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before that might affect this study's results.I have not had major surgery recently.I need extra oxygen or have trouble breathing due to lung problems.I have taken drugs to suppress my immune system recently.I can join the study even if my disease can't be measured.I haven't taken specific cancer drugs recently.I have had a stem cell transplant within the required time frame.I have not received any live vaccines recently.I have had a disease affecting my brain or spinal cord.I am 18 years or older.I've had bad reactions to CAR-T cell therapy before.I have not had certain immune treatments recently.I do not have any active infections.My side effects from previous cancer treatments are mild or gone.I am fully active or can carry out light work.I have a serious heart condition.My multiple myeloma has returned or didn't respond to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cevostamab
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.
What risk factors are associated with Cevostamab usage?
"Cevostamab was given a rating of 2 on the safety scale due to its Phase 2 trial status; there is evidence attesting to its protection but nothing that can back up claims of efficacy."
Answered by AI
Does this clinical research offer the opportunity for participants?
"According to information from clinicaltrials.gov, this medical trial is not actively accepting patients at present. First posted on May 1st 2023 and most recently edited on April 7th 2023, the study does not currenlty require participants; however, there are 803 alternative studies currently recruiting individuals for their respective trials."
Answered by AI
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