Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma
NCT06179888 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2026-05-13
Summary
This phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel (a type of chimeric antigen receptor T-cell \[CAR-T\] therapy) for multiple myeloma. The usual approach after treatment with idecabtagene vicleucel is to monitor the multiple myeloma without giving myeloma medications. There is currently no medication approved specifically for use after idecabtagene vicleucel treatment. Upon administration, iberdomide modifies the immune system and activates immune cells called T-cells, which could enhance the effectiveness of idecabtagene vicleucel. Iberdomide may keep multiple myeloma under control for longer than the usual approach (disease monitoring) after idecabtagene vicleucel, and may help multiple myeloma patients live longer.
Conditions
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood samples
- PROCEDURE
-
Bone Marrow Aspiration
Undergo bone marrow aspiration
- PROCEDURE
-
Bone Marrow Biopsy
Undergo bone marrow biopsy
- PROCEDURE
-
Computed Tomography
Undergo PET/CT and/or CT
- DRUG
-
Given PO
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Patient Monitoring
Undergo disease monitoring
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT
- PROCEDURE
-
Skeletal Survey X-Ray
Undergo skeletal survey x-ray
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Sascha A Tuchman · Alliance for Clinical Trials in Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-27
- Primary Completion
- 2027-10-31
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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