A Phase II Randomized Study of Three Subcutaneous Bortezomib-based Consolidation Treatments for Patients Completing Induction Therapy and Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
24 months
No
Craig B. Reeder, M.D.
Principal Investigator
Mayo Clinic in Arizona
United States: Food and Drug Administration
MC1186
NCT01706666
December 2012
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Baylor Medical Center | Garland, Texas 75042 |