Conditions: Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief summary:
To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.

Detailed description:
PRIMARY OBJECTIVES

* Establish the maximum tolerated dose (MTD) and toxicity profile for the combination of amrubicin with lenalidomide and dexamethasone in previously treated adult patients with multiple myeloma during Phase I
* Determine the combined rate of complete response (CR) and very good partial response (VGPR) for this combination in this population as defined by the International Myeloma Working Group Uniform Response Criteria (IMWGURC)

SECONDARY OBJECTIVES

* Determine the overall response rate (CR, VGPR and PR)
* Assess additional evidence of ant-tumor activity as measured by duration of response (DOR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS)

Arms:
arm 1: Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.

Concurrent therapeutic medications:

* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)

Other drugs:

* Aspirin: 81 or 325 mg daily oral
* Pegfilgrastim subcutaneous on Day 2

Interventions: intervention 1: Amrubicin intervention 2: Lenalidomide intervention 3: Dexamethasone intervention 4: Aspirin intervention 5: Pegfilgrastim
Intervention descriptions: intervention 1: 40, 60, or 80 mg/m2 intravenous (IV) intervention 2: 15 mg daily by mouth intervention 3: 40 mg weekly by mouth intervention 4: 81 or 325 mg daily by mouth intervention 5: 6 mg subcutaneous on Day 2

Protocol document: