National Cancer Institute (NCI)
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.
PRIMARY OBJECTIVES: I. To establish and confirm the safety and dose of iberdomide as maintenance after idecabtagene vicleucel (ide-cel) CAR-T. (Safety run-in) II. To assess whether iberdomide maintenance therapy after idecabtagene vicleucel CAR-T cell therapy increases progression-free survival (PFS) relative to observation without additional therapy. (Randomized phase II) SECONDARY OBJECTIVES: I. To demonstrate anti-tumor activity, defined as conversion from non-minimal residual disease (MRD) complete response (CR)/stringent CR (sCR) status to MRD-negative CR/sCR, as well as improvement in…
Inclusion Criteria: * 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 sti…
Undergo collection of blood samples
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo PET/CT and/or CT
Given PO
Undergo MRI
Undergo disease monitoring
Undergo PET/CT
Undergo skeletal survey x-ray