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CC-92480 + Other Drugs for Multiple Myeloma
Phase 1 & 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or refractory multiple myeloma (MM) with documented disease progression during or after their last myeloma therapy
Refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
Study Summary
This trial is testing a new drug for people with multiple myeloma who have relapsed or are unresponsive to other treatments.
Who is the study for?
This trial is for adults with Multiple Myeloma that has come back or didn't respond to treatment. They must have measurable disease, be in good physical condition (ECOG PS of 0 or 1), and not suitable for other effective treatments. Participants can't join if they've had certain prior therapies, recent stem-cell transplants, CNS involvement by MM, recent SARS-CoV-2 infection, major surgery, radiation therapy, anti-myeloma drugs or investigational agents within specific time frames.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of CC-92480 (BMS-986348) combined with other drugs like BMS-986158, Trametinib, Dexamethasone and Tazemetostat in treating Relapsed/Refractory Multiple Myeloma. It aims to find out how well these combinations work together.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion such as fever or chills; blood disorders; fatigue; issues affecting heart function; digestive problems like nausea or diarrhea; skin changes; nerve damage leading to symptoms like numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has worsened despite treatment.
Select...
My multiple myeloma hasn't responded to, or I can't tolerate, standard treatments.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Establish dosing schedule of each combination for Part 2 Dose Expansion
Establish recommended Phase 2 dose (RP2D)
Number of participants with adverse events (AEs)
Secondary outcome measures
Area under the concentration-time curve (AUC)
Complete response rate (CRR)
Duration of response (DOR)
+6 moreTrial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 Arm G: Dose ExpansionExperimental Treatment3 Interventions
Group II: Part 2 Arm F: Dose ExpansionExperimental Treatment3 Interventions
Group III: Part 2 Arm E: Dose ExpansionExperimental Treatment3 Interventions
Group IV: Part 1 Arm C: Dose FindingExperimental Treatment3 Interventions
Group V: Part 1 Arm B: Dose FindingExperimental Treatment3 Interventions
Group VI: Part 1 Arm A: Dose FindingExperimental Treatment3 Interventions
Group VII: Part 2 Arm D: Dose ExpansionActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Dexamethasone
FDA approved
BMS-986158
Not yet FDA approved
CC-92480
2018
Completed Phase 1
~150
Tazemetostat
FDA approved
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,640 Previous Clinical Trials
4,129,244 Total Patients Enrolled
87 Trials studying Multiple Myeloma
29,700 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My multiple myeloma has worsened despite treatment.My multiple myeloma hasn't responded to, or I can't tolerate, standard treatments.I have previously been treated with CC-92480, tazemetostat, BMS-986158, or trametinib.I haven't had major surgery, certain therapies, or a COVID-19 vaccine recently.You must have a disease that can be measured.I have had a stem-cell transplant from a donor or my own within the last 12 weeks.I am fully active or can carry out light work.I have previously been treated with CC-92480.My multiple myeloma has affected or previously affected my brain or spinal cord.I had a mild COVID-19 infection less than 14 days ago or a severe one less than 28 days ago.I have a specific blood disorder such as plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or significant light-chain amyloidosis.I have heart problems that affect my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Arm A: Dose Finding
- Group 2: Part 2 Arm G: Dose Expansion
- Group 3: Part 2 Arm F: Dose Expansion
- Group 4: Part 1 Arm C: Dose Finding
- Group 5: Part 2 Arm D: Dose Expansion
- Group 6: Part 1 Arm B: Dose Finding
- Group 7: Part 2 Arm E: Dose Expansion
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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 currently opportunities to join the trial as a participant?
"Affirmative. Records on clinicaltrials.gov demonstrate that this research project, which was initially advertised on October 31st 2022, is currently recruiting participants. A total of 220 patients need to be sourced from 4 separate medical sites."
Answered by AI
How many medical facilities have implemented this clinical experiment?
"Currently, the trial is accepting enrollees at 4 sites. These include New york, Toronto, Birmingham and other cities with convenient access for participants. To minimize travel requirements it's beneficial to select a nearby centre."
Answered by AI
How many participants has this experiment attracted?
"To complete this medical trial, 220 patients who meet the stated requirements must be enrolled. Those interested in participating may do so from Memorial Sloan Kettering Cancer Center (New york City) and Local Institution - 0004 (Toronto)."
Answered by AI
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