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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503442-30-00

Acronym

64007957MMY3005

Enrollment

563

Registered

2024-08-26

Start date

2022-10-14

Completion date

Unknown

Last updated

2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

Dual primary endpoints: PFS; 12-month MRD-negative CR

Interventions

DRUGLenalidomide Mylan 10 mg hard capsules

DRUGLenalidomide Accord 15 mg hard capsules

DRUGFortecortin® 2 mg Tabletten

DRUGLenalidomide Mylan 25 mg hard capsules

DRUGLenalidomide Mylan 5 mg hard capsules

DRUGDexamethason 4 mg JENAPHARM®

DRUGDexamethasone Tablets BP 2.0mg

DRUGDARZALEX 1800 mg solution for injection

DRUGDexamethason 8 mg GALEN® Tabletten

DRUGPrivigen 100 mg/ml solution for infusion

DRUGteclistamab

DRUGLenalidomide Accord 5 mg hard capsules

DRUGJNJ-64407564

DRUGLenalidomide Mylan 15 mg hard capsules

DRUGLenalidomide Accord 25 mg hard capsules

DRUGLenalidomide Accord 10 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dual primary endpoints: PFS; 12-month MRD-negative CR	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026