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
- Conditions
- Multiple Myeloma
- Registration Number
- 2023-503442-30-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
To compare the efficacy of Tec-DR versus DRd and Tal-DR versus DRd
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 563
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
Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 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
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dual primary endpoints: PFS; 12-month MRD-negative CR Dual primary endpoints: PFS; 12-month MRD-negative CR
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (87)
HELIOS Klinikum Berlin-Buch GmbH
🇩🇪Berlin, Germany
Universitaetsklinikum Essen AöR
🇩🇪Essen, Germany
Universitaetsklinikum Wuerzburg AöR
🇩🇪Wuerzburg, Germany
Universitaetsklinikum Tuebingen AöR
🇩🇪Tuebingen, Germany
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinikum Nuernberg
🇩🇪Nuremberg, Germany
Martin-Luther-Universitaet Halle-Wittenberg
🇩🇪Halle (Saale), Germany
Region Midtjylland
🇩🇰Herning, Denmark
Sygehus Lillebaelt Vejle Sygehus
🇩🇰Vejle, Denmark
Næstved Hospital
🇩🇰Næstved, Denmark
Scroll for more (77 remaining)HELIOS Klinikum Berlin-Buch GmbH🇩🇪Berlin, GermanySnjezana JanjetovicSite contact00493094010Snjezana.Janjetovic@helios-gesundheit.de