Conditions: Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Keywords: Maintenance Consolidation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare the stringent complete response (sCR) rate after 12 cycles among arms.

SECONDARY OBJECTIVES:

I. To compare progression-free and overall survival among arms. II. To describe the adverse event profile of each arm.

TERTIARY OBJECTIVES:

I. To compare sCR after 6 cycles and 24 cycles and quality of life among arms.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive bortezomib subcutaneously (SC) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

ARM B: Patients receive bortezomib SC as in Arm A, cyclophosphamide orally (PO) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

ARM C: Patients receive bortezomib SC as in Arm A and lenalidomide PO once daily (QD) on days 1-28.

In all arms, treatment continues every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years.

Arms:
arm 1: Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. arm 2: Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. arm 3: Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.

Interventions: intervention 1: bortezomib intervention 2: cyclophosphamide intervention 3: lenalidomide intervention 4: laboratory biomarker analysis intervention 5: dexamethasone intervention 6: quality-of-life assessment
Intervention descriptions: intervention 1: Given SC intervention 2: Given PO intervention 3: Given PO intervention 4: Correlative studies intervention 5: Given PO intervention 6: Ancillary studies

Protocol document: