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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)
Nantes University Hospital·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Multiple Myeloma
Drug/Device/Intervention
Teclistamab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Nantes University Hospital
Location
Bayonne,Caen,Dijon,La Roche-sur-Yon,Lille,Limoges,Lyon,Marseille,Montpellier,Nantes,Paris,Paris,Paris,Pessac,Poitiers,Rennes,Strasbourg,Toulouse,Tours,Vandœuvre-lès-Nancy, France
Timeline & enrollment
Phase
Phase 2
Start date
Apr 20, 2024
End date
Jun 20, 2030
Enrollment
103 participants
Primary outcome

Rate of sustained MRD negativity (NGS, 10^-5),Rate of conversion from positive MRD to negative MRD (NGS, 10^-5)

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.

ICD-10 classifications
Multiple myelomaMultiple myeloma and malignant plasma cell neoplasmsOther myeloid leukaemiaMyeloid leukaemiaOther myelodysplastic syndromes
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06353022
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06353022 through Pure Global AI's free database. This Phase 2 trial is sponsored by Nantes University Hospital and is currently Not yet recruiting. The study focuses on Multiple Myeloma. Target enrollment is 103 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.