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Monoclonal Antibodies
Cevostamab for Multiple Myeloma
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
Participants must have relapsed or refractory (R/R) multiple myeloma (MM) for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have tried other treatments without success, are not pregnant or breastfeeding, and can perform daily activities with minimal assistance. They must not have had certain recent treatments, transplants, major surgeries, infections including COVID-19 within specific time frames, a history of severe allergies to monoclonal antibodies, or any condition that could interfere with the study.Check my eligibility
What is being tested?
The study tests different doses of Cevostamab given through IV infusion to see how safe it is and how well it works in treating multiple myeloma that has come back or hasn't responded to treatment. Tocilizumab may also be used if needed. It's an early-phase trial where researchers closely monitor participants' reactions.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drug components which might cause symptoms ranging from mild skin rashes to more serious issues like difficulty breathing. Other potential side effects are not specified but generally could involve typical chemotherapy-related issues such as fatigue, nausea, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has returned or hasn't responded to treatment, and I can't use or tolerate standard therapies.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Arms E and J Only: Incidence and Severity of Cytokine-release Syndrome (CRS) Following Tocilizumab Premedication Followed by Treatment with Cevostamab
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Percentage of Participants with Adverse Events (AEs)
Secondary outcome measures
AUC of Tocilizumab
Area Under the Concentration-Time Curve (AUC) of Cevostamab
CL of Tocilizumab
+12 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: Arm K: Compressed Double Step Dose Expansion for CevostamabExperimental Treatment1 Intervention
In Cycle 1, participants will receive 2 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 4, and 8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
Group II: Arm J: Expansion Phase for Tocilizumab PretreatmentExperimental Treatment2 Interventions
All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.
Group III: Arm I: Triple Step Dose Expansion for CevostamabExperimental Treatment1 Intervention
The triple step dose expansion stage of the study may use the dosing and assessment schedule from the triple step dose escalation arm in Cycle 1, based on data from Arm H.
Group IV: Arm H: Triple Step Dose Escalation for CevostamabExperimental Treatment1 Intervention
In Cycle 1, participants will receive 3 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 2-4, 8, and 9-11. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
Group V: Arm G: Double Step Dose Expansion for CevostamabExperimental Treatment1 Intervention
The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.
Group VI: Arm F: Single Step Dose Expansion for CevostamabExperimental Treatment1 Intervention
The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.
Group VII: Arm E: Expansion Phase for Tocilizumab PretreatmentExperimental Treatment2 Interventions
All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.
Group VIII: Arm D: Double Step Dose Expansion for CevostamabExperimental Treatment1 Intervention
The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.
Group IX: Arm C: Single Step Dose Expansion for CevostamabExperimental Treatment1 Intervention
The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.
Group X: Arm B: Double Step Dose Escalation for CevostamabExperimental Treatment1 Intervention
In Cycle 1, participants will receive 2 step-up doses and a target dose. The step-up dose will be given on Cycle 1 Day 1 and C1D8. The target dose will be given on C1D15. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
Group XI: Arm A: Single Step Dose Escalation for CevostamabExperimental Treatment1 Intervention
Study drug will be administered intravenously on a 21-day cycle. The step-up dose will be given on Cycle 1 Day 1 and the target dose will be given on C1D8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
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?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,723 Total Patients Enrolled
23 Trials studying Multiple Myeloma
6,078 Patients Enrolled for Multiple Myeloma
Clinical TrialsStudy DirectorGenentech, Inc.
2,201 Previous Clinical Trials
888,520 Total Patients Enrolled
19 Trials studying Multiple Myeloma
2,788 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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)."
Answered by AI
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."
Answered by AI
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