Comparing 4 approaches for multiple myeloma

Inclusion

• +for Dose-Expansion:
• +≥ 18 years of age
• +ECOG score ≤ 1
• +Multiple myeloma (as per IMWG)
• +Prior therapy for MM: Participants must have received at least 1 and up to 3 prior lines of therapy as defined by IMWG, and the following drug classes: PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, IMiD, and anti-CD38 antibody. For mezigdomide combination CohortsCohortA group of participants sharing a characteristic, followed together.Read more → B1 and B2, participants must have received at least 2 prior lines of therapy
• +Participants must have a confirmed diagnosis of progressive MM (per IMWG), t(4;14) confirmed by fluorescence in situ hybridization (FISH) testing performed in a centralized Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory via fresh tumor biopsy.
• +Measurable disease, including at least 1 of the following criteria:
• +Serum M protein ≥ 0.50 g/dL (by SPEP)
• +Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)
• +Urine M protein ≥ 200 mg/24 h (by UPEP)
• +sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)
• +Bone marrow plasma cells ≥ 30% (if only criterion for measurability)
• +Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)
• +Key Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for Dose-Expansion:
• +Treatment with the following therapies in the specified time period prior to first dose:
• +Patients in Cohorts B1 and B2 must not have received prior mezigdomide treatment
• +Carfilzomib in the immediate last prior line of therapy for patients enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in Cohorts C1 and C2
• +Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
• +Cellular therapies ≤ 8 weeks
• +Autologous transplant \< 100 days
• +Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD
• +Current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis
• +Active CNS disease: participants with previously treated stable CNS disease are eligible, except for Cohorts B1 and B2 for which known CNS myeloma involvement is completely excluded.
• +Inadequate bone marrow function
• +Inadequate renal, hepatic, pulmonary, and cardiac function
• +Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocolProtocolThe detailed plan a study must follow.Read more →.
• +Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 7 days or 5 half-lives (whichever is longer) prior to first dose
• +Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)
• +Active malignancy not related to myeloma requiring therapy within \< 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.
• +Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
• +Major surgery ≤ 4 weeks