protocolSection identificationModule nctId: NCT06353022, orgStudyIdInfo id: RC23_0267, secondaryIdInfos id: 2023-508310-41, type: EUDRACT_NUMBER, briefTitle: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma, acronym: IFm2022-01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-04-20, completionDateStruct date: 2030-06-20, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: Janssen Pharmaceutica, descriptionModule briefSummary: 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., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 103, type: ESTIMATED, armsInterventionsModule interventions name: Teclistamab, interventions name: Talquetamab, interventions name: Lenalidomide, interventions name: Bortezomib, interventions name: Daratumumab, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: Rate of sustained MRD negativity (NGS, 10^-5), primaryOutcomes measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5), secondaryOutcomes measure: Number of adverse events, secondaryOutcomes measure: Rate of sustained MRD negativity (NGS, 10^-6), secondaryOutcomes measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-6)., secondaryOutcomes measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5)., secondaryOutcomes measure: Number of the death, secondaryOutcomes measure: Number of responses, secondaryOutcomes measure: Number of progression-free survival, secondaryOutcomes measure: Percentage of duration of response, secondaryOutcomes measure: Percenatge of time to response, otherOutcomes measure: Percentage of value of biological prognostic factors influencing outcome and response., otherOutcomes measure: Percentage of score of quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH de la Côte Basque, city: Bayonne, zip: 64109, country: France, geoPoint lat: 43.48333, lon: -1.48333, locations facility: CHU Caen, city: Caen, zip: 14033, country: France, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CHRU DIjon, city: Dijon, zip: 21000, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Chd Vendee, city: La Roche-sur-Yon, zip: 85925, country: France, geoPoint lat: 46.66667, lon: -1.43333, locations facility: CHRU LILLE - Hôpital Claude Huriez, city: Lille, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHU Limoges, city: Limoges, zip: 87000, country: France, geoPoint lat: 45.83153, lon: 1.25781, locations facility: CH Lyon Sud, city: Lyon, zip: 69495, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: IPC Marseille Institut Paoli Calmettes, city: Marseille, zip: 13009, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU Montpellier, city: Montpellier, zip: 34295, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU de Nantes, city: Nantes, zip: 44093, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: APHP Hôpital Saint Louis, city: Paris, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP Hôpital Saint-Antoine, city: Paris, zip: 75012, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP Hôpital La Pitié Salpétrière, city: Paris, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU BORDEAUX - Hôpital du Haut Lévêque, city: Pessac, zip: 33604, country: France, geoPoint lat: 44.81011, lon: -0.64129, locations facility: CHU Poitiers, city: Poitiers, zip: 86000, country: France, geoPoint lat: 46.58333, lon: 0.33333, locations facility: CHRU Rennes - Hôpital de Pontchaillou, city: Rennes, zip: 35033, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: ICANS Institut de Cancérologie Strasbourg Europe, city: Strasbourg, zip: 67200, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: CHU Toulouse, city: Toulouse, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: CHU Tours Hôpital Bretonneau, city: Tours, zip: 37044, country: France, geoPoint lat: 47.38333, lon: 0.68333, locations facility: CHRU Nancy - Hôpitaux de Brabois, city: Vandœuvre-lès-Nancy, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, hasResults: False