Brief Summary
Intervention / Treatment
- Drug: Sonrotoclax
- Drug: Dexamethasone
- Drug: Carfilzomib
- Drug: Daratumumab
- Drug: Pomalidomide
Inclusion Criteria:
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 to 2
- A confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of multiple myeloma (must have an M-component in serum and/or urine)
- Measurable disease defined as:
i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
- Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.
ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.
- In Part 1 should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses, and no more available approved therapies.
- Participants in Part 2 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy
- Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.
- Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory
a. fresh bone marrowsoft, spongy tissue found in bones that makes blood cells aspirateto draw out fluid or tissue from the body, often with a syringe sample must be collected at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening and sent to central laboratory for t(11;14) FISH testing.
- Adequate organ function defined as:
- Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
- Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
- Absolute neutrophil count (ANC) ≥ 1000/mm^3 within 7 days before first dose of study treatment
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be < 3 x ULN for patients with Gilbert’s syndrome)