A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Recruiting now · Phase 3
Conditions studied: Multiple Myeloma
In brief
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).
Key facts
- Study ID
- NCT05552222
- Run by
- Janssen Research & Development, LLC
- People needed
- 1590
- Starts
- 2022-10-25
- Expected to finish
- 2033-10-28
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 to 2
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
- A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
You may not qualify if…
- Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization
- Had plasmapheresis within 28 days of randomization
- Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
- Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
- Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone
Where it is running
- University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
- UCSF Fresno — Clovis, California, United States (enrolling)
- City of Hope Duarte — Duarte, California, United States (enrolling)
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
- Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
- Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
- University of Connecticut — Farmington, Connecticut, United States (enrolling)
- Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
- ChristianaCare Helen F Graham Cancer Center and Research Institute — Newark, Delaware, United States (enrolling)
- Memorial Healthcare System — Hollywood, Florida, United States (enrolling)
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando — Orlando, Florida, United States (enrolling)
- Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
- City of Hope Cancer Center — Newnan, Georgia, United States (enrolling)
- University Of Illinois Medical Center — Chicago, Illinois, United States (enrolling)
- Loyola University Medical Center — Maywood, Illinois, United States (enrolling)
- University of Iowa Health Care — Waukee, Iowa, United States (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
- LSUHSC Shreveport Feist-Weiller Cancer Center — Shreveport, Louisiana, United States (enrolling)
- Johns Hopkins University School of Medicine JHUSOM — Baltimore, Maryland, United States (enrolling)
- Center for Cancer and Blood Disorders — Bethesda, Maryland, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion — Detroit, Michigan, United States (enrolling)
- Cancer And Hematology Centers of Western Michigan PC — Grand Rapids, Michigan, United States (enrolling)
- Henry Ford Providence Novi Hospital — Novi, Michigan, United States (enrolling)
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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