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
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
- DrugTeclistamab
Teclistamab will be administered as SC injection.
- DrugDaratumumab
Daratumumab will be administered as SC injection.
- DrugLenalidomide
Lenalidomide will be administered orally.
- DrugDexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
- DrugTalquetamab
Talquetamab will be administered as SC injection.
Locations (265)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- University of Arizona Cancer CenterTucson, Arizona
- UCSF FresnoClovis, California
- City of Hope DuarteDuarte, California
- City of Hope Orange County Lennar Foundation Cancer CenterIrvine, California
- Cancer and Blood Specialty ClinicLos Alamitos, California