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Proteasome Inhibitor
Mezigdomide + Carfilzomib + Dexamethasone for Multiple Myeloma (SUCCESSOR-2 Trial)
Phase 3
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Summary
This trial is testing a new drug called Mezigdomide combined with two other drugs to treat patients whose blood cancer has come back or not responded to previous treatments. The new drug aims to stop cancer cells from growing and spreading.
Who is the study for?
This trial is for individuals with multiple myeloma who've had at least one prior treatment, including lenalidomide and an anti-CD38 monoclonal antibody. They should have shown some response to previous treatments and must have disease progression after the last regimen. Those previously treated with mezigdomide or carfilzomib, or recent stem cell transplant recipients cannot participate.
What is being tested?
The SUCCESSOR-2 study is testing Mezigdomide combined with Carfilzomib and Dexamethasone (MeziKD) against just Carfilzomib and Dexamethasone (Kd). The goal is to see which combination works better for relapsed or refractory multiple myeloma.
What are the potential side effects?
Potential side effects include immune system suppression leading to infections, blood clots, fatigue, nausea, diarrhea, muscle pain, fever from infusion reactions. Long-term risks may involve bone marrow suppression causing anemia or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Complete Response (CR) Or Better (CRR)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)Experimental Treatment3 Interventions
Group II: Kd (Carfilzomib + Dexamethasone)Active Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Mezigdomide
2023
Completed Phase 1
~40
Carfilzomib
2017
Completed Phase 3
~1430
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Myeloma include immunomodulatory drugs (IMiDs) like Mezigdomide, proteasome inhibitors, and monoclonal antibodies. IMiDs induce apoptosis in myeloma cells and enhance the immune system's ability to target these cells.
Proteasome inhibitors, such as carfilzomib, disrupt protein degradation in cancer cells, leading to cell death. Monoclonal antibodies, like daratumumab, specifically target antigens on myeloma cells, facilitating their destruction by the immune system.
These mechanisms are crucial as they offer multiple pathways to attack myeloma cells, improving treatment efficacy and patient outcomes.
Experimental approaches in the treatment of multiple myeloma.
Experimental approaches in the treatment of multiple myeloma.
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,124,904 Total Patients Enrolled
90 Trials studying Multiple Myeloma
21,903 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with mezigdomide or carfilzomib.I have been treated with lenalidomide and an anti-CD38 drug for at least 2 cycles.I have been diagnosed with multiple myeloma and it can be measured.I have undergone treatment for myeloma before.My myeloma has worsened despite my last treatment.I have seen improvement in my myeloma after treatment.I have had a stem cell transplant from a donor or my own within the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
- Group 2: Kd (Carfilzomib + Dexamethasone)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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