Hackensack Meridian Health
This is a prospective, 2-arm (with an additional exploratory arm), open-label, multicenter study looking at the response rate of patients receiving selinexor (KPT-330), in combination with carfilzomib, daratumumab or pomalidomide. Multiple Myeloma patients with documented disease progression or refractory disease while on current treatment with any carfilzomib-containing regimen (arm 1), any pomalidomide-containing regimen (arm 2) or any daratumumab-containing regimen (exploratory arm) will be included in the study. Patients will be assigned to the respective groups according to their current treatment. If a subject has received more than one of the above therapies, then assignment will be made at their physician's discretion (e.g treatment decision can be made based upon patient and physician preferred tolerance.). Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard of care, or withdrawal, whichever occurs first.
This is a Phase 2b, two-arm, open-label, multicenter study of Sd (selinexor 100, 80 or 60 mg) in combination with carfilzomib, or pomalidomide in patients with MM previously treated with carfilzomib or pomalidomide respectively, and refractory to prior treatment. An additional exploratory arm will focus on patients treated with SD in combination with daratumumab. This study will enroll approximately 96 patients overall (43 in each of the arms and 10 additional patients in the exploratory arm. Patients will be assigned to the respective arms based on their previous treatment. Patients who are…
Inclusion Criteria: 1. Age ≥18 years at time of informed consent. 2. Histologically confirmed MM and evidence of disease progression while on one of the below MM regimens: * Arm 1: Refractory to or disease progression while on a carfilzomib-containing regimen * Arm 2: Refractory to or disease progression while on a pomalidomide-containing regimen * Exploratory Arm: Refractory to or disease progression while on a daratumumab-containing regimen 3. Measurable disease as defined: Serum M-protein ≥ 0.5 g/dL; urine M-protein excretion at least 200 mg/24h; serum FLC ≥ 100 mg/L, provided th…
Selinexor 60 mg PO on days 1, 8 and 15
Selinexor 80 mg PO on days 1, 8 and 15
Selinexor 100 mg PO on days 1, 8, 15 and 22
56 mg/m2 IV on days 1, 8 and 15
4 mg PO daily for 21 days
16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on
20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22