RecruitingMultiple Myeloma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

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About this study

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).

Sponsor: Janssen Research & Development, LLC

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