NCT02203643

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.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 477 (actual)
• Sponsor: Mario Boccadoro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. The duration of the study is approximately 5 years.

Conditions

• MULTIPLE MYELOMA (MM)

Interventions

Type	Name	Description
DRUG	Carfilzomib
DRUG	Cyclophosphamide
DRUG	Lenalidomide
DRUG	Dexamethasone

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-10-01
• Completion: 2026-03-30
• First posted: 2014-07-30
• Last updated: 2026-04-14

Locations

1 site across 1 country: Italy