This feasibility trial studies the efficacy of administering iberdomide (CC-220) as a priming agent prior to leukapheresis in patients with relapsed/refractory multiple myeloma (RRMM) who are already planned for standard-of-care CAR-T therapy. Giving iberdomide before CAR-T may improve T cell fitness which may improve CAR-T expansion kinetics and response after infusion.
Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with either cilta-cel or ide-cel.
Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Subjects with active plasma cell leukemia (defined as either 20% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L)
Subjects with active Central Nervous System involvement with multiple myeloma
Subjects with active multiple myeloma that cannot be safely managed with single-agent iberdomide for the duration of the priming period, per the discretion of the treating physician or PI
Single group
Iberdomide
Drug1.0mg iberdomide capsules administered orally, daily on days 1-21 of a 28-day cycle
CAR-T Leukapheresis
Procedure/SurgeryA procedure in which blood is collected and white blood cells (including T cells) are separated and collected. The remaining blood components are returned to the participant. The collected T cells will be used to manufacture the CAR-T cell therapy.
CAR-T Infusion
Procedure/SurgeryParticipants will receive an intravenous infusion of standard-of-care CAR-T therapy manufactured from the participant's previously collected cells
Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming.
Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming, defined as an absolute increase of \>10 percentage points or a relative increase of \>50% in TEM cells.
Change in Proportion of T cell subsets from baseline after iberdomide priming
Proportion of T cell subsets (including terminally differentiated effector, exhausted, and activated T cells) present for each participant in the feasibility evaluable (FE) population at leukapheresis (Priming D29 after iberdomide) to baseline (Priming-D1).
Cmax with iberdomide priming prior to leukapheresis
Cmax is the highest measured concentration of iberdomide. Cmax will be assessed in the CAR-T evaluable (CARTE) population
Tmax with iberdomide priming prior to leukapheresis,
Time to reach Cmax. Tmax will be assessed in CAR-T (CARTE) population
AUC0-14 with iberdomide priming prior to leukapheresis
Total Exposure over time. AUC0-14 will be assessed in the CAR-T evaluable (CARTE) population.
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Shambavi Richard
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Bristol-Myers Squibb
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
