Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

Paused · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT06179888
Run by: National Cancer Institute (NCI)
People needed: 84
Starts: 2024-08-27
Expected to finish: 2027-10-31
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0):
All patients must be pre-registered. For patients who consent to biobanking, submit the bone marrow and blood specimens
Note: Patients who do not consent to the optional biobanking must be pre-registered, but specimens should not be submitted for these patients
Please ensure patient has suspected diagnosis of multiple myeloma and meets on study guidelines prior to informed consent and biospecimen collection
In cases where the bone marrow aspiration may be inadequate at Step 0 registration, the patient may still register on study
ELIGIBILITY CRITERIA (STEP 1):
Patients must have diagnostically confirmed MM in response status of stable disease or better by International Myeloma Working Group (IMWG) criteria 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
Adverse events related to ide-cel are required to have resolved to grade =< 1 except fatigue, alopecia, and other events that are unlikely to interfere with study assessments or pose a safety risk to participants
Patients must have had ≥ 2 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. Refractoriness is defined as per published IMWG criteria; progression while on iberdomide or within 60 days of stopping iberdomide
Patients who have received MM-directed therapy since ide-cel infusion are not eligible, with the exception of short-course steroids for managing ide-cel toxicity as described below
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors
Platelet count ≥ 75,000/mm\^3
Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors
Calculated (calc.) creatinine clearance >= 30 mL/min by Modification of Diet in Renal Disease (MDRD)
Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors
Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x upper limit of normal (ULN)
Platelet transfusions or use of growth factors for neutropenia (e.g., filgrastim, tbo-filgrastim, sagramostim) or thrombocytopenia (romiplostim or eltrombopag) are not permitted to meet enrollment criteria. Specific cutoffs are one week for short-acting myeloid growth factors for neutropenia, and two weeks for all platelet growth factors or long-acting (usually pegylated) myeloid growth factors
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown.

Where it is running

Cedars-Sinai Medical Center — Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
Augusta University Medical Center — Augusta, Georgia, United States
University of Illinois — Chicago, Illinois, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
Iowa Methodist Medical Center — Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
Baptist Memorial Hospital and Cancer Center-Desoto — Southhaven, Mississippi, United States
Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
Siteman Cancer Center-South County — St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
Nebraska Medicine-Bellevue — Bellevue, Nebraska, United States
Nebraska Medicine-Village Pointe — Omaha, Nebraska, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
Memorial Sloan Kettering Commack — Commack, New York, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States

Full record on ClinicalTrials.gov

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