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
Purpose
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).
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR) |
Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide. |
|
|
Experimental Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR) |
Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide. |
|
|
Active Comparator Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) |
Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone. |
|
Recruiting Locations
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC