RandPhIIStIberdomideMaintaenanceThepFollowIdecabtageneVicleucelCARTMultipleMyeloma

UCI Specialty Area: Cancer

Principal Investigator: Lisa Xingguang Lee

Official Title: Randomized Phase II Study of Iberdomide Maintenance Therapy Following Idecabtagene Vicleucel CAR-T in Multiple Myeloma patients

A Study On:

Multiple Myeloma

Study Description

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.

Eligibility

-Patients must have diagnostically confirmed Multiple Myeloma at day 80-110 post-infusion of ide-cel. Patients in deep remission (e.g., CR, MRD-negative, etc.), are eligible.

-All patients are required to have received ide-cel CAR-T within 80-110 days of registration.

-Patients must have had ≥ 4 lines of therapy for MM (this includes proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody).

-Prior therapy with iberdomide is permitted but prior iberdomide refractoriness is prohibited.

-Age ≥ 18 years

-Labs need to be within normal range.

-Not pregnant and not nursing

-Male patients must agree to use an adequate method of contraception

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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