Clinical trial NCT01794039
Conditions: Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma
Sponsor: Mayo Clinic
Start date: 2014-03-01; Completion date: 2016-11-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well pomalidomide and dexamethasone work compared to lenalidomide and dexamethasone in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) or did not respond to previous treatment with lenalidomide (refractory). Pomalidomide and lenalidomide may help the immune system kill cancer cells and may also prevent the growth of new blood vessels that tumors need to grow. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone may also help pomalidomide and lenalidomide work better by making cancer cells more sensitive to the drugs. It is not yet known whether pomalidomide and dexamethasone or lenalidomide and dexamethasone are effective in treating patients with relapsed or refractory multiple myeloma.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the confirmed response rate of the combination of lenalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm A) II. To assess the confirmed response rate of the combination of pomalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm B)

SECONDARY OBJECTIVES:

I. To assess the toxicity in each arm in patients with relapsed myeloma who have previously received lenalidomide.

II. To assess the response rates with pomalidomide and dexamethasone in patients relapsing on lenalidomide and dexamethasone. (Arm A) III. To assess time to progression and overall survival with each approach.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive lenalidomide orally (PO) daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.

ARM B: Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. arm 2: Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Dexamethasone intervention 2: Lenalidomide intervention 3: Pomalidomide
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Given PO

Protocol documents: