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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

NCT05552222

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Multiple Myeloma

Interventions: Teclistamab, Daratumumab, Lenalidomide, Dexamethasone, Talquetamab

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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

Exclusion Criteria:

* 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

Locations (270)

Gilbert, Arizona, United States
Tucson, Arizona, United States
Clovis, California, United States
Duarte, California, United States
Irvine, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Farmington, Connecticut, United States
New Haven, Connecticut, United States
Newark, Delaware, United States
Hollywood, Florida, United States
Orlando, Florida, United States
Weston, Florida, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Waukee, Iowa, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Novi, Michigan, United States
Southfield, Michigan, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
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