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Iberdomide vs Lenalidomide for Multiple Myeloma
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 12 years
Awards & highlights
Study Summary
This trial compares 2 therapies for multiple myeloma after stem cell transplantation to see which works better.
Who is the study for?
This trial is for individuals with newly diagnosed symptomatic multiple myeloma who've had 3-6 cycles of specific induction therapies and a stem cell transplant within the last year, achieving at least partial response. It's not for those with progressive disease post-transplant, smoldering or nonsecretory myeloma, central nervous system involvement by MM, or other malignancies in the past 5 years.Check my eligibility
What is being tested?
The study compares two maintenance therapies after autologous stem cell transplantation in new multiple myeloma patients: Iberdomide versus Lenalidomide. The goal is to see which one is more effective as a long-term treatment following initial therapy and transplant.See study design
What are the potential side effects?
Potential side effects of Iberdomide and Lenalidomide may include blood disorders like anemia or neutropenia, risk of infections due to low white blood cells, digestive issues such as diarrhea or constipation, fatigue, rash, and possibly increased risk of secondary cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments
Achieving MRD negativity in participants with CR or better at any time after the date of randomization
Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
+14 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm A3: Iberdomide Dose 3Experimental Treatment1 Intervention
Group II: Arm A2: Iberdomide Dose 2Experimental Treatment1 Intervention
Group III: Arm A1: Iberdomide Dose 1Experimental Treatment1 Intervention
Group IV: Arm B: LenalidomideActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iberdomide
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,128,848 Total Patients Enrolled
87 Trials studying Multiple Myeloma
28,704 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had 3-6 cycles of specific cancer treatment and possibly a stem cell transplant.My multiple myeloma has spread to my brain or spinal cord.I have been cancer-free from other types of cancer for over 5 years.I can take care of myself and am up and about more than half of my waking hours.I have been diagnosed with symptomatic multiple myeloma.My condition worsened after stem cell transplant or initial treatment didn't work.My condition is either smoldering myeloma, solitary plasmacytoma, or nonsecretory myeloma.I had a partial response to my treatment for myeloma after a stem cell transplant within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A1: Iberdomide Dose 1
- Group 2: Arm A2: Iberdomide Dose 2
- Group 3: Arm A3: Iberdomide Dose 3
- Group 4: Arm B: Lenalidomide
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical facilities are currently participating in this experimental study?
"Rocky Mountain Cancer Centers in Aurora, Colorado; Poudre Valley Health Care in Fort Collins, Florida; and Mayo Clinic Florida in Jacksonville, Georgia are among the 272 clinical trial sites actively enrolling patients for this medical study."
Answered by AI
How secure is it to take Arm A1: Iberdomide Dose 1?
"Our team has assessed the safety of Arm A1: Iberdomide Dose 1 as 3, indicating that there is existing evidence that supports its efficacy and multiple data points which suggest it can be used safely."
Answered by AI
Are there opportunities for enrollment in this investigational process?
"Evidently, this clinical trial is not presently enrolling any sufferers. Despite being initially published on June 15th 2023 and last updated April 11th 2023, there are no current openings for participation in the study. On the other hand, 807 alternative trials that require volunteers are open at present."
Answered by AI
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