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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: A Phase 2 (IFM 2022-01)
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
CH de la Côte Basque
Bayonne, France
CHU Caen
Caen, France
CHRU DIjon
Dijon, France
Chd Vendee
La Roche-sur-Yon, France
CHRU LILLE - Hôpital Claude Huriez
Lille, France
CHU Limoges
Limoges, France
CH Lyon Sud
Lyon, France
IPC Marseille Institut Paoli Calmettes
Marseille, France
CHU Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
Start Date
June 26, 2024
Primary Completion Date
April 26, 2028
Completion Date
June 26, 2030
Last Updated
March 17, 2026
103
ESTIMATED participants
Teclistamab
DRUG
Talquetamab
DRUG
Lenalidomide
DRUG
Bortezomib
DRUG
Daratumumab
DRUG
Dexamethasone
DRUG
Lead Sponsor
Nantes University Hospital
Collaborators
NCT06179888
NCT06152575
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04973605