A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Janssen Research & Development, LLC

Summary

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria * Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 t…

Interventions

Drug
Teclistamab
Teclistamab will be administered as SC injection.
Drug
Daratumumab
Daratumumab will be administered as SC injection.
Drug
Lenalidomide
Lenalidomide will be administered orally.
Drug
Dexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
Drug
Talquetamab
Talquetamab will be administered as SC injection.

Locations (270)

Banner MD Anderson Cancer Center
Gilbert, Arizona
University of Arizona Cancer Center
Tucson, Arizona
UCSF Fresno
Clovis, California
City of Hope Duarte
Duarte, California
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California
Cancer and Blood Specialty Clinic
Los Alamitos, California