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)

Phase 1 Completed 85 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2015-07-22
Primary completion: 2021-03-19
Completion: 2021-03-19

Publications

Wong S, Hamidi H, Costa LJ, Bekri S, Neparidze N, Vij R, Nielsen TG, Raval A, Sareen R, Wassner-Fritsch E, Cho HJ. Multi-omic analysis of the tumor microenvironment shows clinical correlations in Ph1 study of atezolizumab +/- SoC in MM. Front Immunol. 2023 Jul 25;14:1085893. doi: 10.3389/fimmu.2023.1085893. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	840 mg	Intravenous
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Daratumumab	Monoclonal antibody	16 mg/kg	Intravenous
Comparator	Dexamethasone	Small molecule	20 mg	Oral
Comparator	Dexamethasone	Small molecule	40 mg	Oral
Subject	Lenalidomide	Other / unclassified	10 mg	Oral
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Lenalidomide	Other / unclassified	25 mg	Oral
Subject	Pomalidomide	Other / unclassified	2 mg	Oral
Subject	Pomalidomide	Other / unclassified	4 mg	Oral

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

Timeline

Publications

Drugs

Indications