Multiple Myeloma Clinical 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)

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.

View Eligibility Criteria

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 ( Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 40 percent (%)
Total bilirubin Creatinine /=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomide
Corrected calcium at or below ULN
Transaminase levels 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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02431208

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 31 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
University Of Arkansas
Little Rock Arkansas, 72205, United States
Scripps Clinic Torrey Pines
La Jolla California, 92037, United States
UC Davis; Comprehensive Cancer Center
Sacramento California, 95817, United States
University of California, San Francisco
San Francisco California, 94116, United States
Yale University
New Haven Connecticut, 06511, United States
Mayo Clinic Hospital - Florida
Jacksonville Florida, 32224, United States
Emory Univ Winship Cancer Inst
Atlanta Georgia, 30322, United States
Loyola University Med Center
Maywood Illinois, 60153, United States
Indiana University Health; Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
Indiana University Department of Medicine; IU Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Louisville
Louisville Kentucky, 40202, United States
University of Maryland School of Medicine
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston Massachusetts, 02215, United States
Univ of Michigan Medical Ctr
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute.
Detroit Michigan, 48201, United States
Henry Ford Hospital; Hematology Oncology
Detroit Michigan, 48202, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89014, United States
Mount SInai Medical Center
New York New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
UNC Chapel Hill
Chapel Hill North Carolina, 27514, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44915, United States
University of Oklahoma Health Sciences Center; Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Lifespan Cancer Institute
Providence Rhode Island, 02905, United States
Medical University of South Carolina; Hollings Cancer Center
Charleston South Carolina, 29425, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
UT Southwestern MC at Dallas
Dallas Texas, 75390, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02431208

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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