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CAR T-cell Therapy

Iberdomide for Multiple Myeloma

Phase 2
Recruiting
Led By Sascha A Tuchman
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age must be ≥ 18 years
Male patients must use adequate contraception
Must not have
Patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome or amyloidosis involving vital organs
Patients receiving strong CYP3A4 inducers or inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at start of maintenance and at one year post-initiation of maintenance or observation
Awards & highlights
No Placebo-Only Group

Summary

This trial compares using iberdomide maintenance therapy with just monitoring the disease to see if it can help patients with multiple myeloma who have already received idecabtagene vicleucel therapy

Who is the study for?
This trial is for adults over 18 with multiple myeloma who've had CAR-T therapy (idecabtagene vicleucel) within the past 80-110 days. They should be in stable condition or better and haven't taken any other myeloma treatments since, except possibly short steroids for CAR-T side effects. People can't join if they're resistant to Iberdomide or have had certain recent therapies.
What is being tested?
The study compares maintenance therapy using a drug called Iberdomide against just monitoring the disease after CAR-T treatment for multiple myeloma. The goal is to see if Iberdomide helps patients live longer by keeping cancer under control better than no further treatment.
What are the potential side effects?
Iberdomide may affect the immune system, potentially causing fatigue, digestive issues, and increasing infection risk. It's designed to activate T-cells which could lead to inflammation or other immune-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am using effective birth control methods.
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My multiple myeloma is stable or improving after recent treatment.
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My kidney function, measured by creatinine clearance, is good.
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I am HIV-positive, on treatment, and my viral load is undetectable.
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I had hepatitis C but have been treated and cured.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have undergone 4 or more treatments for multiple myeloma.
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I do not have POEMS syndrome or amyloidosis affecting vital organs.
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I can swallow pills without any issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have POEMS syndrome or amyloidosis affecting vital organs.
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I am not taking any strong medication that affects liver enzymes.
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I cannot swallow pills due to a medical condition.
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I have had a condition where my lymphocytes grow abnormally.
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I have received treatment for multiple myeloma after ide-cel infusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) (randomized phase II)
Secondary study objectives
Best response achieved while on study
Incidence of adverse events
Number of treatment cycles received (tolerability)
+4 more
Other study objectives
B-cell maturation antigen (BCMA) protein expression
MRD-negativity rate
Peripheral blood immunophenotype
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (iberdomide)Experimental Treatment8 Interventions
Patients receive iberdomide PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo PET/CT and/or skeletal survey x-ray, CT, or MRI at screening and then as clinically indicated.
Group II: Group 1 (monitoring)Active Control8 Interventions
Patients undergo disease monitoring at monthly clinic visits until disease progression. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo PET/CT and/or skeletal survey x-ray, CT, or MRI at screening and then as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iberdomide
2021
Completed Phase 1
~60
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Skeletal Survey X-Ray
2021
Completed Phase 2
~10
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,887 Previous Clinical Trials
41,020,935 Total Patients Enrolled
590 Trials studying Multiple Myeloma
189,247 Patients Enrolled for Multiple Myeloma
Sascha A TuchmanPrincipal InvestigatorAlliance for Clinical Trials in Oncology
~52 spots leftby Oct 2027
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