A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM)

PHASE1CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

July 22, 2015

Primary Completion Date

March 19, 2021

Study Completion Date

March 19, 2021

Conditions
Multiple Myeloma
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Dexamethasone

Participants will receive either 20mg or 40mg of dexamethasone PO every 7 days from Day 1 of each cycle.

Trial Locations (31)

10029

Mount SInai Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

21201

University of Maryland School of Medicine, Baltimore

27514

UNC Chapel Hill, Chapel Hill

29425

Medical University of South Carolina; Hollings Cancer Center, Charleston

30322

Emory Univ Winship Cancer Inst, Atlanta

32224

Mayo Clinic Hospital - Florida, Jacksonville

35249

University of Alabama at Birmingham, Birmingham

44915

Cleveland Clinic Foundation, Cleveland

46202

Indiana University Department of Medicine; IU Simon Cancer Center, Indianapolis

46526

Indiana University Health; Goshen Center for Cancer Care, Goshen

48201

Karmanos Cancer Institute., Detroit

48202

Henry Ford Hospital; Hematology Oncology, Detroit

60153

Loyola University Med Center, Maywood

63110

Washington University School of Medicine, St Louis

72205

University Of Arkansas, Little Rock

73104

University of Oklahoma Health Sciences Center; Stephenson Cancer Center, Oklahoma City

75246

Texas Oncology-Baylor Sammons Cancer Center, Dallas

75390

UT Southwestern MC at Dallas, Dallas

77030

Houston Methodist Cancer Center, Houston

89014

Comprehensive Cancer Centers of Nevada, Henderson

92037

Scripps Clinic Torrey Pines, La Jolla

94116

University of California, San Francisco, San Francisco

95817

UC Davis; Comprehensive Cancer Center, Sacramento

98109

Seattle Cancer Care Alliance, Seattle

06511

Yale University, New Haven

40202-1798

University of Louisville, Louisville

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Med Ctr; Hem/Onc, Boston

48109-0718

Univ of Michigan Medical Ctr, Ann Arbor

02905

Lifespan Cancer Institute, Providence

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02431208 - A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM) | Biotech Hunter | Biotech Hunter