85
Participants
Start Date
July 22, 2015
Primary Completion Date
March 19, 2021
Study Completion Date
March 19, 2021
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Participants will receive intravenous (IV) atezolizumab until loss of clinical benefit, withdrawal, or study end. Cohorts A to C will receive 1200 milligrams (mg) on Day 1 of each 21-day cycle. Cohorts D to F (combination with daratumumab) will receive 840 mg on Days 2 and 16 of Cycle 1 and on Days 1 and 15 of each 28-day cycle thereafter.
Daratumumab
Participants will receive 16 milligrams per kilogram (mg/kg) IV daratumumab until loss of clinical benefit, withdrawal, or study end. Treatment will be per the U.S. Package Insert and given on Days 1, 8, 15, 22 of Cycles 1 and 2; on Days 1 and 15 of Cycles 3 to 6; and on Day 1 of each 28-day cycle thereafter.
Lenalidomide
Lenalidomide will be administered orally (PO) until loss of clinical benefit, withdrawal, or study end. Cohort B1 will receive 10, 15, or 25 mg, ascending-dose lenalidomide, on Days 1-14 of each 21-day cycle. Cohort C will receive 10 mg on Days 1-14 of each 21-day cycle, beginning in Cycle 4. Cohort E (combination with daratumumab) will receive 10, 15, or 25 mg on Days 1-21 of each 28-day cycle. Participants in Cohort E1 will receive ascending-dose lenalidomide, and those in Cohort E2 will receive lenalidomide at the MTD as determined in Cohort E1.
Pomalidomide
Pomalidomide will be administered PO until loss of clinical benefit, withdrawal, or study end. Cohort F (combination with daratumumab) will receive 2 or 4 mg on Days 1-21 of each 28-day cycle. Participants in Cohort F1 will receive ascending-dose pomalidomide, and those in Cohort F2 will receive pomalidomide at the MTD as determined in Cohort F1.
Dexamethasone
Participants will receive either 20mg or 40mg of dexamethasone PO every 7 days from Day 1 of each cycle.
Mount SInai Medical Center, New York
Memorial Sloan-Kettering Cancer Center, New York
University of Maryland School of Medicine, Baltimore
UNC Chapel Hill, Chapel Hill
Medical University of South Carolina; Hollings Cancer Center, Charleston
Emory Univ Winship Cancer Inst, Atlanta
Mayo Clinic Hospital - Florida, Jacksonville
University of Alabama at Birmingham, Birmingham
Cleveland Clinic Foundation, Cleveland
Indiana University Department of Medicine; IU Simon Cancer Center, Indianapolis
Indiana University Health; Goshen Center for Cancer Care, Goshen
Karmanos Cancer Institute., Detroit
Henry Ford Hospital; Hematology Oncology, Detroit
Loyola University Med Center, Maywood
Washington University School of Medicine, St Louis
University Of Arkansas, Little Rock
University of Oklahoma Health Sciences Center; Stephenson Cancer Center, Oklahoma City
Texas Oncology-Baylor Sammons Cancer Center, Dallas
UT Southwestern MC at Dallas, Dallas
Houston Methodist Cancer Center, Houston
Comprehensive Cancer Centers of Nevada, Henderson
Scripps Clinic Torrey Pines, La Jolla
University of California, San Francisco, San Francisco
UC Davis; Comprehensive Cancer Center, Sacramento
Seattle Cancer Care Alliance, Seattle
Yale University, New Haven
University of Louisville, Louisville
Massachusetts General Hospital, Boston
Beth Israel Deaconess Med Ctr; Hem/Onc, Boston
Univ of Michigan Medical Ctr, Ann Arbor
Lifespan Cancer Institute, Providence
Hoffmann-La Roche
INDUSTRY