- Active, not recruiting
NCT02203643: Phase 2 - Carf/Cyclo./Dex Vs Carf/Len/Dex -> ASCT or 12 Cy Carf/Len/Dex - NDMM - FORTE
Updated: Aug 27, 2022
FORTE STUDY
NCT02203643: Phase 2 - Carf/Cyclo./Dex Vs Carf/Len/Dex -> ASCT or 12 Cy Carf/Len/Dex - NDMM - FORTE
KRd
KCd
ITALIAN STUDY
Evaluation of the Safety and the Efficacy of Carfilzomib Combined With Cyclophosphamide and Dexamethasone (CCyd) or Lenalidomide and Dex (CRd) Followed by ASCT or 12 Cycles of Carf Combined With Dex and Len for Patients Eligible for ASCT With Newly Diagnosed Multiple Myeloma. (FORTE)
This study will evaluate the safety and the efficacy of carfilzomib combined with cyclophosphamide and dexamethasone (CCyd) or lenalidomide and dexamethasone (CRd) followed by autologous transplantation ASCT or 12 cycles of carfilzomib combined with dexamethasone and lenalidomide for patients eligible for ASCT with newly diagnosed multiple myeloma. As a secondary endpoint this study will evaluate the best maintenance treatment between lenalidomide and lenalidomide combined with carfilzomib. Four hundred seventy-seven patients, males and females aged > 18 years, enrolled in several sites, will take part in this study.
University of Turin, Italy
The duration of the study is approximately 5 years.
Sponsor:
Mario Boccadoro
Information provided by (Responsible Party):
Mario Boccadoro, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02203643
Official Title: A MULTICENTER, RANDOMIZED, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (CCyd) as Pre Transplant INDUCTION and Post Transplant Consolidation or CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (CRd) as Pre Transplant INDUCTION and Post Transplant Consolidation or Continuous Treatment With CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (12 Cycles) Without Transplant, All Followed by MAINTENANCE With LENALIDOMIDE (R) Versus LENALIDOMIDE AND CARFILZOMIB (CR) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT
https://clinicaltrials.gov/ct2/show/NCT02203643
Carfilzomib : National Cancer Institute
Carfilzomib : MedlinePlus Drug Information
Lenalidomide: National Cancer Institute
Lenalidomide: MedlinePlus Drug Information
Dexamethasone : National Cancer Institute
Dexamethasone : MedlinePlus Drug Information
ASCO Annual meeting 2021
Abstract 8002
Program: Oral and Poster Abstracts
Type: Oral
Session: 731. Clinical Autologous Transplantation: Autologous Transplantation: Still the Backbone of Modern Myeloma Therapies; Hematology Disease Topics & Pathways
Saturday, December 5, 2020: 9:30 AM
GIMEMA, European Myeloma Network, Italy
62nd ASH Annual meeting and exposition
Dec 5-8, 2020
2019 ASCO Annual meeting
NCT02203643: Phase 2 - Carf/Cyclo./Dex Vs Carf/Len/Dex -> ASCT or 12 Cy Carf/Len/Dex - NDMM - FORTE
Carfilzomib with cyclophosphamide and dexamethasone or lenalidomide and dexamethasone plus autologous transplantation or carfilzomib plus lenalidomide and dexamethasone, followed by maintenance with carfilzomib plus lenalidomide or lenalidomide alone for patients with newly diagnosed multiple myeloma (FORTE): a randomised, open-label, phase 2 trial
Lancet Oncol; 2021
Learn more:
https://pubmed.ncbi.nlm.nih.gov/34774221/
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00535-0/fulltext
OAB-011 Predictors of Unsustained Negativity in Minimal Residual Disease (MRD)-Negative Transplant-Eligible Newly Diagnosed Multiple Myeloma (MM) Patients Enrolled in the FORTE Trial -Mattia D'Agostino
#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California
https://www.myelomasociety.org/