• 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

FORTE STUDY


NCT02203643: Phase 2 - Carf/Cyclo./Dex Vs Carf/Len/Dex -> ASCT or 12 Cy Carf/Len/Dex - NDMM - FORTE

KRd

KCd

Forte STUDY

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

 

Carfilzomib-based induction/consolidation with or without autologous transplant (ASCT) followed by lenalidomide (R) or carfilzomib-lenalidomide (KR) maintenance: Efficacy in high-risk patients.


ASCO Annual meeting 2021

Abstract 8002

 

141 Survival Analysis of Newly Diagnosed Transplant-Eligible Multiple Myeloma Patients in the Randomized Forte Trial


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

 

Efficacy of carfilzomib lenalidomide dexamethasone (KRd) with or without transplantation in newly diagnosed myeloma according to risk status: Results from the FORTE trial.


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

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 





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