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Cevostamab for Multiple Myeloma
Study Summary
This trial is testing a new cancer drug in people with multiple myeloma that has come back or does not respond to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have or might have a long-term EBV infection or hepatitis C.I have not had major surgery in the last 4 weeks.I haven't had any antibody-based cancer treatments in the last 4 weeks.I haven't had cancer treatment in the last 4 weeks or within 5 half-lives of the drug.You have a disease that can be measured with lab tests.I have a history of autoimmune disease or a brain infection.I agree not to donate sperm and to use contraception during and for 2 months after treatment.You are expected to live for at least 12 more weeks.You have too many plasma cells in your blood.I have or had a brain disease or my multiple myeloma has spread to my brain.I have heart problems that could affect my response to a severe reaction.I need extra oxygen because of my lung condition.You have a positive blood test for hepatitis B virus (HBV) infection.I haven't had a live vaccine in the last 4 weeks and don't plan to during the study.My multiple myeloma has returned or hasn't responded to treatment, and I can't use or tolerate standard therapies.Side effects from my previous cancer treatment are mild, except for hair loss or nerve issues.I am not pregnant or breastfeeding and do not plan to become pregnant soon.I had a stem cell transplant using my own cells less than 100 days ago.I have had a previous transplant of bone marrow or an organ.I have been diagnosed with amyloidosis confirmed by a tissue biopsy.My cancer is near vital organs and could worsen suddenly.I haven't had CAR T-cell therapy in the last 12 weeks.I have a history of HLH or MAS.I haven't had a serious infection or needed IV antibiotics in the last 4 weeks.I have a positive test for EBV or CMV.I am HIV positive.I have not had symptomatic COVID-19 or needed IV treatment for it in the last 14 days.I agree to use birth control and not breastfeed during and for 5 months after treatment.I haven't had immunotherapy for at least the shorter of 12 weeks or 5 half-lives of the drug before starting this trial.You have misused drugs or alcohol in the past year before screening.You have had serious allergic reactions to a specific type of medication called monoclonal antibodies.I haven't taken strong immune system medications, except for low-dose steroids, in the last 2 weeks.I am fully active or can carry out light work.I have had side effects from previous immune therapy.I have had cancer before that might interfere with this study.
- Group 1: Arm J: Expansion Phase for Tocilizumab Pretreatment
- Group 2: Arm I: Triple Step Dose Expansion for Cevostamab
- Group 3: Arm A: Single Step Dose Escalation for Cevostamab
- Group 4: Arm G: Double Step Dose Expansion for Cevostamab
- Group 5: Arm K: Compressed Double Step Dose Expansion for Cevostamab
- Group 6: Arm F: Single Step Dose Expansion for Cevostamab
- Group 7: Arm B: Double Step Dose Escalation for Cevostamab
- Group 8: Arm C: Single Step Dose Expansion for Cevostamab
- Group 9: Arm H: Triple Step Dose Escalation for Cevostamab
- Group 10: Arm E: Expansion Phase for Tocilizumab Pretreatment
- Group 11: Arm D: Double Step Dose Expansion for Cevostamab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any vacancies yet for this clinical trial?
"Current information available on clinicaltrials.gov reveals this trial is accruing participants, which began to be sought after since the 19th of September 2017 and was last updated at the beginning of October 2022."
How many facilities are currently involved in this experiment?
"The University of Colorado Denver, Sarah Cannon Research Institute in Nashville and the University of Alabama at Birmingham are all participating sites for this clinical trial. In addition, 13 other medical centres across America have also joined in on the study."
What degree of risk is inherent with the use of Cevostamab?
"Cevostamab's safety has been documented to a limited extent, warranting it an overall score of 1."
How is Cevostamab typically employed in medical treatment?
"Cevostamab has been demonstrated to be a viable treatment for juvenile idiopathic arthritis (both polyarticular and systemic varieties), as well as cytokine release syndrome resulting from CAR-T cell therapy."
What is the cap for participant enrollment in this trial?
"Genentech, Inc. is the sponsor of this research project and it requires 420 participants that meet the eligibility criteria to take part in the study. Two locations offering participation are University of Colorado Denver (Aurora) and Sarah Cannon Research Institute (Nashville)."
Are there any past experiments that have utilized Cevostamab?
"At this point in time, there are 71 experiments pertaining to Cevostamab with 8 of them being at Phase 3. While a few studies for the medication occur in Poznan and New york City, clinical trials for it sprawl across 1455 sites worldwide."
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