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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)

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Daratumumab

Lenalidomide

Pomalidomide

Dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previous diagnosis of MM with objective evidence of measurable disease
Willing and able to undergo bone marrow aspiration and biopsy tissue sample collection during screening and on study
Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (</=) 2
Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 40 percent (%)
Total bilirubin </=2 times the ULN
Creatinine </=2.0 milligrams per deciliter (mg/dL), with creatinine clearance (CrCl) using the Cockcroft-Gault formula >/=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomide
Corrected calcium at or below ULN
Transaminase levels </=2.5 times the upper limit of normal (ULN)
Receipt of >/=1 but not more than 3 prior lines of therapy (Cohorts A, B, C, D1, E)
Receipt of 2, but not more that 3 prior lines of therapy that must have included a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) (alone or in combination, and are refractory to the last line of treatment(Cohort D2)
Receipt of >/=2 prior lines of therapy and progressed on treatment with an anti-CD38 monoclonal antibody and are refractory to both a PI and IMiD (Cohort D3)
Receipt of >/=4 lines of prior therapy and are refractory to the last line of treatment (Cohort F)
Absolute neutrophil count (ANC) >/=1000 cells per microliter (cells/mcL) (Cohorts A, B, D, E, F)
Platelet count >/=50,000 cells/mcL, or >/=30,000 cells/mcL if more than 50% bone marrow involvement (Cohorts A, B, D, E, F)
All participants who are prescribed lenalidomide or pomalidomide must be counseled at a minimum of every 21-28 days about pregnancy precautions and risks of fetal exposure (Cohorts B, C, E, F)
Agree to be registered in and comply with all requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program (Cohorts B, C, E)
Agree to be registered in and comply with all requirements of the Pomalyst REMS program (Cohort F)
Sufficient recovery from first or second ASCT within 60-120 days of transplant (Cohort C)
Off antibiotic/antifungal therapy for >/=14 days (Cohort C)
Completion of any prior radiotherapy (Cohort C)
ANC >/=1500 cells/mcL (Cohort C)

Exclusion Criteria:

Other malignancy within 2 years prior to screening, with some exceptions
Prior therapy with atezolizumab or other immunotherapies including CD137 agonists, anti-programmed death (PD)-1, anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4), and anti-PD-L1 therapeutic antibodies
Uncontrolled cancer pain
Treatment with any investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer
Known hypersensitivity to study drug and/or drug class
History of autoimmune disease except for controlled, treated thyroidism or Type 1 diabetes
Prior systemic anti-myeloma therapy within 14 days of Cycle 1 Day 1
Prior treatment with chimeric antigen receptor (CAR) T cells or other forms of adoptive cellular therapy, with the exception of autologous stem cell transplantation
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome
Plasma cell leukemia (greater than 2,000 cells/mcL of circulating plasma cells by standard differential)
Immunosuppressive therapy within 6 weeks of Cycle 1 Day 1
Daily corticosteroid requirement within 2 weeks of Cycle 1 Day 1
Prior allogeneic stem cell transplant or solid organ transplant
Active hepatitis B, active hepatitis C, or positive for human immunodeficiency virus (HIV)
Uncontrolled, clinically significant pulmonary disease (for example, chronic obstructive pulmonary disease, pulmonary hypertension, idiopathic pulmonary fibrosis) that in the opinion of the investigator would put the participant at significant risk for pulmonary complications during the study
History of pneumonitis
Uncontrolled intercurrent illness including but not limited to uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or breastfeeding females
Inability to tolerate thromboprophylaxis (Cohorts B, C, E, F)
Evidence of progressive MM compared to pretransplant evaluation (Cohort C)
Prior treatment with anti-CD38 therapy including daratumumab (Cohorts D1, D2, E, F)

Sites / Locations

University of Alabama at Birmingham
University Of Arkansas
Scripps Clinic Torrey Pines
UC Davis; Comprehensive Cancer Center
University of California, San Francisco
Yale University
Mayo Clinic Hospital - Florida
Emory Univ Winship Cancer Inst
Loyola University Med Center
Indiana University Health; Goshen Center for Cancer Care
Indiana University Department of Medicine; IU Simon Cancer Center
University of Louisville
University of Maryland School of Medicine
Massachusetts General Hospital
Beth Israel Deaconess Med Ctr; Hem/Onc
Univ of Michigan Medical Ctr
Karmanos Cancer Institute.
Henry Ford Hospital; Hematology Oncology
Washington University School of Medicine
Comprehensive Cancer Centers of Nevada
Mount SInai Medical Center
Memorial Sloan-Kettering Cancer Center
UNC Chapel Hill
Cleveland Clinic Foundation
University of Oklahoma Health Sciences Center; Stephenson Cancer Center
Lifespan Cancer Institute
Medical University of South Carolina; Hollings Cancer Center
Texas Oncology-Baylor Sammons Cancer Center
UT Southwestern MC at Dallas
Houston Methodist Cancer Center
Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Active Comparator

Arm Label

Cohort A: ATZ (Run-In)

Cohort B1: ATZ + LEN (Dose Escalation)

Cohort C: ATZ + LEN (Post-ASCT):

Cohort D1: ATZ + DAR (Run-in)

Cohort D2: ATZ + DAR (Expansion)

Cohort D3: ATZ + DAR (Progressed)

Cohort E1: ATZ + DAR + LEN (Dose Escalation)

Cohort E2: ATZ + DAR + LEN (Expansion)

Cohort F1: ATZ + DAR + POM (Dose Escalation)

Cohort F2: ATZ + DAR + POM (Expansion)

Cohort F3: DAR + POM + Dexamethasone

Arm Description

Cohort A will involve a safety run-in to evaluate atezolizumab administered as a single agent in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort has been completed.

Cohort B1 will involve a dose escalation to evaluate atezolizumab administered in combination with ascending-dose lenalidomide in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort has been completed.

Cohort C will evaluate atezolizumab administered in combination with lenalidomide in participants with MM who have measureable disease after ASCT. NOTE: This cohort is closed to enrollment.

Cohort D1 will involve a safety run-in to evaluate atezolizumab administered in combination with daratumumab in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment.

Cohort D2 will involve an expansion to evaluate atezolizumab administered in combination with daratumumab in participants with relapsed or refractory MM who have received 2 but no more than 3 lines of prior treatment that must have included a PI and IMiD and are refractory to the last line of treatment.

Cohort D3 will involve an expansion to evaluate atezolizumab in combination with daratumumab in participants with relapsed or refractory MM who have received 2 or more lines of prior treatment and have progressed with an anti-cluster of differentiation (CD) 38 monoclonal antibody, either alone or in combination, and are refractory to both a proteasome inhibitor (PI) and immunomodulatory drug (IMiD).

Cohort E1 will involve a dose escalation to evaluate atezolizumab administered in combination with daratumumab and ascending-dose lenalidomide in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort is closed to enrollment.

Cohort E2 will involve an expansion to evaluate atezolizumab administered in combination with daratumumab and the maximum tolerated dose (MTD) of lenalidomide determined in Cohort E1 in participants with relapsed or refractory MM who have received up to 3 lines of prior treatment. NOTE: This cohort is closed to enrollment.

Cohort F1 will involve a dose escalation to evaluate atezolizumab administered in combination with daratumumab and ascending-dose pomalidomide in participants with relapsed or refractory MM who have received 4 or more lines of prior treatment and are refractory to the last line of treatment. NOTE: This cohort has been completed.

Cohort F2 will involve an expansion to evaluate atezolizumab administered in combination with daratumumab and the MTD of pomalidomide determined in Cohort F1 in participants with relapsed or refractory MM who have received 4 or more lines of prior treatment and are refractory to the last line of treatment. NOTE: This cohort is randomized.

Cohort F3 is an expansion control arm for cohort F2. Participants will receive daratumumab in combination with pomalidomide at the MTD and dexamethasone. NOTE: This cohort is randomized.

Outcomes

Primary Outcome Measures

Percentage of Participants by Best Overall Response According to International Myeloma Working Group (IMWG) Criteria

Recommended Phase II Dose (RP2D) of Lenalidomide in the Combinations Tested

RP2D of Pomalidomide in the Combinations Tested

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Secondary Outcome Measures

Duration of Response (DOR) According to IMWG Criteria

Progression-Free Survival (PFS) According to IMWG Criteria

Percentage of Participants with Objective Response According to IMWG Criteria

Overall Survival

Maximum Observed Serum Concentration (Cmax) of Atezolizumab

Predose (0 h) and postdose (0.5 h) (infusion = 0.5-1 h) on Day 1 of Cycles 1, 3 (cycle = 21 or 28 days) and Day 2 of Cycle 1; predose (0 h) on Day 1 of Cycles 2, 4, 8; then every 8 cycles until/at treatment discontinuation (up to 36 months); and 90 days after last dose (up to 36 months overall)

Minimum Observed Serum Concentration (Cmin) of Atezolizumab

Cmax of Lenalidomide

Cmin of Lenalidomide

Cmax of Pomalidomide

Cmin of Pomalidomide

Cmax of Daratumumab

Predose (0 h) and postdose (0.5 h) (infusion ~3-6 h) on Day 1 of Cycles 1, 3 (cycle = 28 days); predose (0 h) on Day 1 of Cycles 2, 4, 8; then every 8 cycles until/at treatment discontinuation (up to 36 months); and 90 days after last dose (up to 36 months overall)

Cmin of Daratumumab

Change in Number of Participants With Anti-Drug Antibody (ADA) Response to Atezolizumab from Baseline to End of Study

From treatment start until study end; assessed predose (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8 (cycle = 21 or 28 days) and Day 2 of Cycle 1; then every 8 cycles until/at treatment discontinuation (up to 36 months); and 90 days after last dose (up to 36 months overall)

Change in Number of Participants With ADA Response to Daratumumab from Baseline to End of Study

Full Information

NCT ID

NCT02431208

First Posted

April 27, 2015

Last Updated

March 31, 2021

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02431208

Brief Title

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)

Official Title

A Phase Ib Study of the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Patients With Multiple Myeloma (Relapsed/Refractory and Post-Autologous Stem Cell Transplantation)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

July 22, 2015 (Actual)

Primary Completion Date

March 19, 2021 (Actual)

Study Completion Date

March 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A: ATZ (Run-In)

Arm Type

Experimental

Arm Description

Arm Title

Cohort B1: ATZ + LEN (Dose Escalation)

Arm Type

Experimental

Arm Description

Arm Title

Cohort C: ATZ + LEN (Post-ASCT):

Arm Type

Experimental

Arm Description

Cohort C will evaluate atezolizumab administered in combination with lenalidomide in participants with MM who have measureable disease after ASCT. NOTE: This cohort is closed to enrollment.

Arm Title

Cohort D1: ATZ + DAR (Run-in)

Arm Type

Experimental

Arm Description

Arm Title

Cohort D2: ATZ + DAR (Expansion)

Arm Type

Experimental

Arm Description

Arm Title

Cohort D3: ATZ + DAR (Progressed)

Arm Type

Experimental

Arm Description

Arm Title

Cohort E1: ATZ + DAR + LEN (Dose Escalation)

Arm Type

Experimental

Arm Description

Arm Title

Cohort E2: ATZ + DAR + LEN (Expansion)

Arm Type

Experimental

Arm Description

Arm Title

Cohort F1: ATZ + DAR + POM (Dose Escalation)

Arm Type

Experimental

Arm Description

Arm Title

Cohort F2: ATZ + DAR + POM (Expansion)

Arm Type

Active Comparator

Arm Description

Arm Title

Cohort F3: DAR + POM + Dexamethasone

Arm Type

Active Comparator

Arm Description

Cohort F3 is an expansion control arm for cohort F2. Participants will receive daratumumab in combination with pomalidomide at the MTD and dexamethasone. NOTE: This cohort is randomized.

Intervention Type

Drug

Intervention Name(s)

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Other Intervention Name(s)

Tecentriq, MPDL3280A, "ATZ"

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Daratumumab

Other Intervention Name(s)

Darzalex, "DAR"

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid, "LEN"

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pomalidomide

Other Intervention Name(s)

Pomalyst, "POM"

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants by Best Overall Response According to International Myeloma Working Group (IMWG) Criteria

Time Frame

From Day 1 of Cycle 2 (cycle = 21 or 28 days) until progression, withdrawal, or study end (up to 36 months overall)

Title

Recommended Phase II Dose (RP2D) of Lenalidomide in the Combinations Tested

Time Frame

From start of treatment until 30 days after last dose (up to approximately 36 months)

Title

RP2D of Pomalidomide in the Combinations Tested

Time Frame

From start of treatment until 30 days after last dose (up to approximately 36 months)

Title

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time Frame

From start of treatment until 30 days after last dose (up to approximately 36 months)

Secondary Outcome Measure Information:

Title

Duration of Response (DOR) According to IMWG Criteria

Time Frame

From first observed response until the date of first recorded progression or death from any cause (up to 36 months overall)

Title

Progression-Free Survival (PFS) According to IMWG Criteria

Time Frame

From start of treatment until the date of first recorded progression or death from any cause (up to 36 months overall)

Title

Percentage of Participants with Objective Response According to IMWG Criteria

Time Frame

From Day 1 of Cycle 2 until progression, withdrawal, or study end (up to 36 months overall). For Cohort D3 Only: 6, 9, and 12 months.

Title

Overall Survival

Time Frame

From start of treatment until death from any cause (up to 36 months overall)

Title

Maximum Observed Serum Concentration (Cmax) of Atezolizumab

Description

Time Frame

From predose (0 hours [h]) on Day 1 of Cycle 1 until treatment discontinuation (up to 36 months overall); see Outcome Measure Description for details

Title

Minimum Observed Serum Concentration (Cmin) of Atezolizumab

Time Frame

Predose (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8 (cycle = 21 or 28 days) and Day 2 of Cycle 1; then every 8 cycles until/at treatment discontinuation (up to 36 months); and 90 days after last dose (up to 36 months overall)

Title

Cmax of Lenalidomide

Time Frame

Predose (0 h) and postdose (1 h) on Day 1 of Cycles 1, 4 (cycle = 21 days); predose (0 h) and postdose (0.5, 1, 2, 4, 8 h) on Day 15 of Cycles 1, 3; predose (0 h) and postdose (2 h) on Day 15 of Cycles 2, 4, 8

Title

Cmin of Lenalidomide

Time Frame

Predose (0 h) on Day 1 of Cycles 1, 4 (cycle = 21 days) and Day 15 of Cycles 1, 2, 3, 4, 8

Title

Cmax of Pomalidomide

Time Frame

Predose (0 h) and postdose (1, 2, 4, 6, 8 h) on Day 15 of Cycles 1, 3 (cycle = 28 days); predose (0 h) and postdose (4 h) on Day 15 of Cycles 2, 4, 8

Title

Cmin of Pomalidomide

Time Frame

Predose (0 h) on Day 15 of Cycles 1, 2, 3, 4, 8 (cycle = 28 days)

Title

Cmax of Daratumumab

Description

Time Frame

From predose (0 h) on Day 1 of Cycle 1 until treatment discontinuation (up to 36 months overall); see Outcome Measure Description for details

Title

Cmin of Daratumumab

Time Frame

Predose (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8 (cycle = 28 days); then every 8 cycles until/at treatment discontinuation (up to 36 months); and 90 days after last dose (up to 36 months overall)

Title

Change in Number of Participants With Anti-Drug Antibody (ADA) Response to Atezolizumab from Baseline to End of Study

Description

Time Frame

From treatment start until study end (up to 36 months overall); see Outcome Measure Description for details

Title

Change in Number of Participants With ADA Response to Daratumumab from Baseline to End of Study

Time Frame

From treatment start until study end; assessed predose (0 h) on Day 1 of Cycles 1, 3, 8 (cycle = 28 days); at treatment discontinuation (up to 36 months); and 90 days after last dose (up to 36 months overall)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Previous diagnosis of MM with objective evidence of measurable disease Willing and able to undergo bone marrow aspiration and biopsy tissue sample collection during screening and on study Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (</=) 2 Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 40 percent (%) Total bilirubin </=2 times the ULN Creatinine </=2.0 milligrams per deciliter (mg/dL), with creatinine clearance (CrCl) using the Cockcroft-Gault formula >/=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomide Corrected calcium at or below ULN Transaminase levels </=2.5 times the upper limit of normal (ULN) Receipt of >/=1 but not more than 3 prior lines of therapy (Cohorts A, B, C, D1, E) Receipt of 2, but not more that 3 prior lines of therapy that must have included a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) (alone or in combination, and are refractory to the last line of treatment(Cohort D2) Receipt of >/=2 prior lines of therapy and progressed on treatment with an anti-CD38 monoclonal antibody and are refractory to both a PI and IMiD (Cohort D3) Receipt of >/=4 lines of prior therapy and are refractory to the last line of treatment (Cohort F) Absolute neutrophil count (ANC) >/=1000 cells per microliter (cells/mcL) (Cohorts A, B, D, E, F) Platelet count >/=50,000 cells/mcL, or >/=30,000 cells/mcL if more than 50% bone marrow involvement (Cohorts A, B, D, E, F) All participants who are prescribed lenalidomide or pomalidomide must be counseled at a minimum of every 21-28 days about pregnancy precautions and risks of fetal exposure (Cohorts B, C, E, F) Agree to be registered in and comply with all requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program (Cohorts B, C, E) Agree to be registered in and comply with all requirements of the Pomalyst REMS program (Cohort F) Sufficient recovery from first or second ASCT within 60-120 days of transplant (Cohort C) Off antibiotic/antifungal therapy for >/=14 days (Cohort C) Completion of any prior radiotherapy (Cohort C) ANC >/=1500 cells/mcL (Cohort C) Exclusion Criteria: Other malignancy within 2 years prior to screening, with some exceptions Prior therapy with atezolizumab or other immunotherapies including CD137 agonists, anti-programmed death (PD)-1, anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4), and anti-PD-L1 therapeutic antibodies Uncontrolled cancer pain Treatment with any investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer Known hypersensitivity to study drug and/or drug class History of autoimmune disease except for controlled, treated thyroidism or Type 1 diabetes Prior systemic anti-myeloma therapy within 14 days of Cycle 1 Day 1 Prior treatment with chimeric antigen receptor (CAR) T cells or other forms of adoptive cellular therapy, with the exception of autologous stem cell transplantation Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome Plasma cell leukemia (greater than 2,000 cells/mcL of circulating plasma cells by standard differential) Immunosuppressive therapy within 6 weeks of Cycle 1 Day 1 Daily corticosteroid requirement within 2 weeks of Cycle 1 Day 1 Prior allogeneic stem cell transplant or solid organ transplant Active hepatitis B, active hepatitis C, or positive for human immunodeficiency virus (HIV) Uncontrolled, clinically significant pulmonary disease (for example, chronic obstructive pulmonary disease, pulmonary hypertension, idiopathic pulmonary fibrosis) that in the opinion of the investigator would put the participant at significant risk for pulmonary complications during the study History of pneumonitis Uncontrolled intercurrent illness including but not limited to uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or breastfeeding females Inability to tolerate thromboprophylaxis (Cohorts B, C, E, F) Evidence of progressive MM compared to pretransplant evaluation (Cohort C) Prior treatment with anti-CD38 therapy including daratumumab (Cohorts D1, D2, E, F)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Facility Name

University Of Arkansas

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Scripps Clinic Torrey Pines

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

UC Davis; Comprehensive Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94116

Country

United States

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Facility Name

Mayo Clinic Hospital - Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Emory Univ Winship Cancer Inst

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Loyola University Med Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Indiana University Health; Goshen Center for Cancer Care

City

Goshen

State/Province

Indiana

ZIP/Postal Code

46526

Country

United States

Facility Name

Indiana University Department of Medicine; IU Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202-1798

Country

United States

Facility Name

University of Maryland School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Beth Israel Deaconess Med Ctr; Hem/Onc

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Univ of Michigan Medical Ctr

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0718

Country

United States

Facility Name

Karmanos Cancer Institute.

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Henry Ford Hospital; Hematology Oncology

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Mount SInai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

UNC Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44915

Country

United States

Facility Name

University of Oklahoma Health Sciences Center; Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Lifespan Cancer Institute

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

Facility Name

Medical University of South Carolina; Hollings Cancer Center

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Texas Oncology-Baylor Sammons Cancer Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

UT Southwestern MC at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Houston Methodist Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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)

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