271
Participants
Start Date
September 12, 2011
Primary Completion Date
November 21, 2023
Study Completion Date
November 21, 2023
CC-122
CC-122 dose in both arms will increase by 1 mg increments starting with 3 mg 5/7 days using the 3+3 design in dose escalation phase. A dose-level -1, with a starting dose of 2mg, may also be evaluated if the opening dose level is not tolerated. At all dose levels in MM-2b arm, DEX will be combined with CC-122 at a starting dose dependent on the subject's age: for subjects who are ≤ 75 years of age, DEX 40 mg/day will be given on Days 1, 8, 15 and 22 of a 28-day cycle and for subjects who are \> 75 years of age, DEX 20 mg/day will be given on Days 1, 8, 15 and 22 of a 28-day cycle. Approximately 33 subjects will be enrolled in the dose escalation phase (15 in each treatment arm). An additional intermittent schedule of 21/28 days may be evaluated per Safety Review Committee (SRC) decision. Following dose escalation, one or two arms will be expanded at or below the MTD in up to 28 subjects (14 subjects in each arm).
CC-122
One or more intermittent schedules of CC-122 either given 5 continuous days out of 7 per week (5/7 days) or 21 continuous days out of 28 days per cycle (21/28 days). Following dose escalation, one or more of these intermittent schedules will be evaluated at a starting dose of 4 mg.
CC-122
Dose escalation on a continous schedule will be evaluated at a starting dose of 4 mg. Specifically, dose levels with 1 mg increments (eg 4mg, 5mg, 6mg etc.) will be evaluated using a 3+3 design as detailed in Part A of the protocol .
CC-122
Up to 10 subjects with relapsed or refractory PCNSL will be enrolled to a PCNSL cohort to evaluate intermittent schedules of CC-122 and to further explore preliminary signals of efficacy and biomarker hypotheses.
Local Institution - 300, Milan
Local Institution - 401, Brussels
Local Institution - 400, Leuven
Local Institution - 103, Badalona (Barcelona)
Mount Sinai Hospital, New York
Local Institution - 020, New York
Local Institution - 201, Marseille Le Cedex
Local Institution - 202, Caen
Local Institution - 301, Rozzano (MI)
Local Institution - 104, Madrid
Local Institution - 102, Madrid
Levine Cancer Institute, Charlotte
MUSC Rheumatology and Immunology Dept., Charleston
Greenville Hospital System, Greenville
Local Institution - 106, Pamplona
Local Institution - 203, Toulouse
Local Institution - 108, Salamanca
Sarah Cannon Research Institute Drug Development Unit, Nashville
Local Institution - 303, Bologna
Local Institution - 305, Bologna
Local Institution - 107, Seville
Local Institution - 100, Valencia
University Of Michigan Comprehensive Cancer Center, Ann Arbor
Local Institution - 205, Pierre-Bénite
Texas Oncology, PA - Dallas 75246, Dallas
South Texas Accelerated Research Therapeutics (START), San Antonio
Local Institution - 302, Napoli, Campania
Comprehensive Cancer Centers Of Nevada, Las Vegas
UCLA Neuro-Oncology Program, Los Angeles
Local Institution - 200, Villejuif
Swedish Medical Center Cancer Institute Research, Seattle
Yakima Valley Memorial Hospital/ North Star Lodge, Yakima
City of Hope Cancer Center, Duarte
UCSF Helen Diller Medical Center at Parnassus Heights, San Francisco
Henry Ford Medical Center - New Center One, Detroit
Rutgers Cancer Institute of New Jersey University, New Brunswick
Local Institution - 304, Roma
Local Institution - 105, Barcelona
Local Institution - 101, Barcelona
Lead Sponsor
Celgene
INDUSTRY