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Brief Title: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma
Official Title: 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 ID: NCT06353022
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
APHP Hôpital Saint Louis, Paris, , France
APHP Hôpital Saint-Antoine, Paris, , France
APHP Hôpital La Pitié Salpétrière, Paris, , France
CHU BORDEAUX - Hôpital du Haut Lévêque, Pessac, , France
CHU Poitiers, Poitiers, , France
CHRU Rennes - Hôpital de Pontchaillou, Rennes, , France
ICANS Institut de Cancérologie Strasbourg Europe, Strasbourg, , France
CHU Toulouse, Toulouse, , France
CHU Tours Hôpital Bretonneau, Tours, , France
CHRU Nancy - Hôpitaux de Brabois, Vandœuvre-lès-Nancy, , France