For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline. Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter. Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
222
CC-5013 - oral - 30mg daily on days 1-21 every 28 days
Palo Verde Hematology Oncology
Glendale, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
Providence St. Joseph Medical Center/Cancer Center
Burbank, California, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States
Myeloma response
Time frame: randomization to progression
Time to tumor progression
Time frame: randomization to progression
Duration of response
Time frame: randomization to progression
Survival (1-year and overall survival)
Time frame: 1 year and ongoing
Time to first skeletal-related event (SRE) (clinical need for radiation or surgery to bone)
Time frame: randomization to progression
Safety (type, frequency, severity, and relationship of adverse events to study drug)
Time frame: ongoing
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Institute for Myeloma and Bone
Los Angeles, California, United States
Cancer Care Associates
Redondo Beach, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
Atlanta Cancer Care-Roswell
Roswell, Georgia, United States
...and 16 more locations