Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

September 12, 2011

Primary Completion Date

November 21, 2023

Study Completion Date

November 21, 2023

Conditions
Multiple MyelomaLymphoma, Large B-Cell, DiffusePleiotropic Pathway ModifierGlioblastomaLymphomaPrimary Central Nervous System Lymphoma
Interventions
DRUG

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).

DRUG

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.

DRUG

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 .

DRUG

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.

Trial Locations (39)

0

Local Institution - 300, Milan

1200

Local Institution - 401, Brussels

3000

Local Institution - 400, Leuven

8916

Local Institution - 103, Badalona (Barcelona)

10029

Mount Sinai Hospital, New York

10065

Local Institution - 020, New York

13273

Local Institution - 201, Marseille Le Cedex

14033

Local Institution - 202, Caen

20089

Local Institution - 301, Rozzano (MI)

28040

Local Institution - 104, Madrid

28041

Local Institution - 102, Madrid

28204

Levine Cancer Institute, Charlotte

29425

MUSC Rheumatology and Immunology Dept., Charleston

29605

Greenville Hospital System, Greenville

31008

Local Institution - 106, Pamplona

31059

Local Institution - 203, Toulouse

37007

Local Institution - 108, Salamanca

37203

Sarah Cannon Research Institute Drug Development Unit, Nashville

40138

Local Institution - 303, Bologna

40139

Local Institution - 305, Bologna

41013

Local Institution - 107, Seville

46010

Local Institution - 100, Valencia

48109

University Of Michigan Comprehensive Cancer Center, Ann Arbor

69495

Local Institution - 205, Pierre-Bénite

75246

Texas Oncology, PA - Dallas 75246, Dallas

78229

South Texas Accelerated Research Therapeutics (START), San Antonio

80131

Local Institution - 302, Napoli, Campania

89169

Comprehensive Cancer Centers Of Nevada, Las Vegas

90095

UCLA Neuro-Oncology Program, Los Angeles

94805

Local Institution - 200, Villejuif

98104

Swedish Medical Center Cancer Institute Research, Seattle

98902

Yakima Valley Memorial Hospital/ North Star Lodge, Yakima

91010-300

City of Hope Cancer Center, Duarte

94143-1270

UCSF Helen Diller Medical Center at Parnassus Heights, San Francisco

48202-268

Henry Ford Medical Center - New Center One, Detroit

08901

Rutgers Cancer Institute of New Jersey University, New Brunswick

00144

Local Institution - 304, Roma

08003

Local Institution - 105, Barcelona

08035

Local Institution - 101, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY