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Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma - Trial NCT06353022

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.

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NCT06353022
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06353022
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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)

Study Focus

Multiple Myeloma

Teclistamab

Interventional

drug

Sponsor & Location

Nantes University Hospital

Bayonne,Caen,Dijon,La Roche-sur-Yon,Lille,Limoges,Lyon,Marseille,Montpellier,Nantes,Paris,Paris,Paris,Pessac,Poitiers,Rennes,Strasbourg,Toulouse,Tours,Vandล“uvre-lรจs-Nancy, France

Timeline & Enrollment

Phase 2

Apr 20, 2024

Jun 20, 2030

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 myeloma
Multiple myeloma and malignant plasma cell neoplasms
Other myeloid leukaemia
Myeloid leukaemia
Other myelodysplastic syndromes

Data Source

ClinicalTrials.gov

NCT06353022

Non-Device Trial