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Iberdomide and Daratumumab for Multiple Myeloma (IBEX Trial)

Phase 2
Recruiting
Led By Jeffery Zonder, M.D.
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have completed Autologous Stem Cell Transplant (ASCT) 90-150 days prior to registration, without any post-ASCT therapy and without post-ASCT disease progression (according to IMWG criteria)
Completed ASCT within 90-150 days prior to registration, without any post-ASCT therapy and without evidence of post-ASCT disease progression (according to IMWG criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

IBEX Trial Summary

This trial is testing if patients with Multiple Myeloma who still have some disease after initial therapy can benefit from continued treatment with Iberdomide and Daratumumab. The trial will assess the

Who is the study for?
This trial is for Multiple Myeloma patients who've had prior therapy with Daratumumab, responded at least partially, completed an Autologous Stem Cell Transplant (ASCT) within the last 90-150 days without progression, and are Minimal Residual Disease positive. They must be physically able to perform daily activities with minimal assistance (ECOG Performance Status ≤2), have adequate bone marrow function and organ function.Check my eligibility
What is being tested?
The trial tests if Iberdomide combined with subcutaneous Daratumumab can effectively maintain remission in Multiple Myeloma patients post-ASCT. It's a phase 2 study where participants receive Iberdomide orally for three weeks of each month and Daratumumab injections weekly initially, then less frequently over up to 26 cycles unless disease progresses.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site from SC Daratumumab, blood cell count changes leading to increased infection risk or bleeding problems, fatigue, liver issues indicated by altered lab results, and kidney impairment as shown by creatinine levels.

IBEX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I finished my stem cell transplant 3-5 months ago, haven't had treatment since, and my condition hasn't worsened.
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I finished my stem cell transplant 3-5 months ago and haven't had treatment or disease progression since.
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My liver tests are within normal limits, except for Gilbert's syndrome.
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My kidney function is good, with a creatinine clearance rate of at least 30 mL/min.
Select...
I can perform daily activities with minimal assistance.
Select...
I have Multiple Myeloma and responded well to my initial DARA therapy.
Select...
I tested positive for minimal residual disease after my stem cell transplant.
Select...
I have completed at least 3 cycles of DARA therapy and saw some improvement.

IBEX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of MRD (-) at 12 months
Secondary outcome measures
Frequency of treatment interruptions and dosage adjustments during maintenance
Overall Survival
Patient reported Quality of Life (QoL) per EORTC QLQ-C30
+5 more

IBEX Trial Design

1Treatment groups
Experimental Treatment
Group I: Iberdomide and DaratumumabExperimental Treatment2 Interventions
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 SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,772 Total Patients Enrolled
88 Trials studying Multiple Myeloma
30,473 Patients Enrolled for Multiple Myeloma
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,196 Total Patients Enrolled
24 Trials studying Multiple Myeloma
1,291 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,268 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,215 Patients Enrolled for Multiple Myeloma
~40 spots leftby Dec 2025
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