Conditions: Multiple Myeloma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.

Detailed description:

Arms:
arm 1: Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 15 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 2: Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 3: Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 4: Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 25 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 5: Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles.

Interventions: intervention 1: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg intervention 2: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg intervention 3: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg intervention 4: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg intervention 5: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Intervention descriptions: intervention 1: Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 2: Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 3: Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 4: Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 5: Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.

Protocol document: