APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory M… (NCT04942067) | Clinical Trial Compass
UnknownPhase 1/2
APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple Myeloma
United States108 participantsStarted 2021-12-23
Plain-language summary
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy, and PK/ Pharmacodynamics of APG-2575 in combination with Pd/DRd in patients with relapsed/refractory (RR) multiple myeloma (MM). The study consists of dose escalation and dose expansion phases. The study consists of will start with 2 arms noted below, both arms are independent
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age
✓. MM patients (for Arm A and Arm B): Patients with Relapsed/Refractory MM per 2016 IMWG criteria, previously treated with at least 1 but not more than 4 prior lines of therapy for MM. Refractory MM, meanwhile, is defined as disease that progresses on salvage therapy or progresses within 60 days of the last treatment.
✓. Eastern Cooperative Oncology Group (ECOG) ≤ 2
✓. Life expectancy ≥ 6 months
✓. Adequate hematologic function defined as:
✓. ANC ≥1.0 x 10\^9/L independent of growth factor support within 7 days of the first dose with study drug
✓. Hemoglobin ≥8 g/dL without transfusion or growth factor support within 7 days of the first dose of study drug
✓. Platelet count ≥ 50 x 10\^9/L without transfusion support within 7 days of the first dose of study drug (for MM patients); or platelet count ≥ 100 x 10\^9/L or ≥ 50 x 10\^9/L if bone marrow involvement independent of transfusion support in either (for AL amyloidosis patients).
Exclusion criteria
✕. MM patients with newly diagnosed MM, previously untreated for MM or only had been treated with localized palliative treatment or steroids less than equivalent of dexamethasone 40 mg daily for 4 days). AL amyloidosis patients with AL amyloidosis have not been treated with any systemic therapy, or AL amyloidosis clinically overt multiple myeloma i.e. original CRAB criteria. Extent of marrow plasmacytosis is not prohibitive.
. Subject has received antineoplastic therapy within 2 weeks before the date of initiating study treatment
✕. Subject has previously received an allogenic stem cell transplant (regardless of timing)
✕. Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, i.e., these subjects should not be enrolled in order to reduce disease burden prior to transplant.
✕. BCL-2-directed therapy within 4 weeks of initiating study treatment. (BCL-2 directed therapy more than 4 weeks before initiation of study treatment is allowed).
✕. For Arm A/C only: The subjects show evidence of intolerance to pomalidomide, which is defined as subjects discontinued due to any AEs related to prior pomalidomide treatment
✕. For Arm B only: The subjects show evidence of intolerance to daratumumab or lenalidomide, which is defined as subjects discontinued due to any AEs related to prior daratumumab or lenalidomide treatment
✕. Patients with any uncontrolled active systemic infection, including but not limited to active hepatitis B or C virus infection, known human immunodeficiency virus (HIV) positive