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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Given SC
Given PO
Given PO
Correlative studies
Given PO
Ancillary studies
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Baylor Medical Center
Garland, Texas, United States
Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months
Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.
Time frame: 24 months
Survival Time
The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.
Time frame: From registration to death due to any cause, assessed up to 3 years
Progression-free Survival
The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.
Time frame: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
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