NCT06353022

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma: A Phase 2 (IFM 2022-01)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively). The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Teclistamab	Maintenance therapy wtih teclistamab (administered via SC injections) for finite duration. Teclistamab will be used in 28 day cycles following initial step up doses
DRUG	Talquetamab	Maintenance therapy with talquetamab (administered via SC injections) for finite duration. Talquetamab will be used in 28 day cycles following initial step up doses
DRUG	Lenalidomide	Induction therapy with lenalidomide: Lenalidomide 25 mg/day oral from Day 1 to Day 21. Maintenance therapy lenalidomide (administered orally) for finite duration.
DRUG	Bortezomib	Induction therapy with Borthezomib Cycle 1 to 6: Bortezomib 1.3 mg/m² SC twice a week on Days 1, 4, 8 and 11
DRUG	Daratumumab	Induction therapy with Daratumumab Cycle 1 to 6 Daratumumab 1800 mg SC on Days 1, 8, 15, 22 of Cycle 1 and Cycle 2 and on Days 1 and 15 of Cycle 3
DRUG	Dexamethasone	Induction therapy with Dexamethasone: cycle 1 to 3 Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22 Cycle 4 to 6 --\> Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22

Timeline

• Start date: 2024-06-26
• Primary completion: 2028-04-26
• Completion: 2030-06-26
• First posted: 2024-04-08
• Last updated: 2026-03-17

Locations

19 sites across 1 country: France