NCT02586038

STUDY THAT COMPARE 3 ARM: MLN9708 DEXAMETHASONE, MLN9708 CYCLOPHOSPHAMIDE AND DEXAMETHASONE, MLN9708 THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY MAINTENANCE WITH MLN9708 IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS

A MULTIARM, OPEN LABEL, RANDOMIZED PHASE II STUDY OF MLN9708 PLUS ORAL DEXAMETHASONE or PLUS ORAL CYCLOPHOSPHAMIDE AND DEXAMETHASONE or PLUS ORAL THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY MAINTENANCE WITH MLN9708 IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Mario Boccadoro · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and the efficacy of the MLN-DEXAMETHASONE, MLN-DEXAMETHASONE-CYCLOPHOSPHAMIDE, or MLN- THALIDOMIDE-DEXAMETHASONE induction combinations, followed by MLN maintenance in newly diagnosed elderly Multiple Myeloma patients. 183 patients, males and females, older than 65 years old or younger but considered not eligible for high-dose chemotherapy and transplantation, enrolled in different sites, will take part in this study. The duration of the study is approximately 5 years.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	MLN9708
DRUG	Dexamethasone
DRUG	Cyclophosphamide
DRUG	Thalidomide

Timeline

• Start date: 2015-10-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2015-10-26
• Last updated: 2024-05-08

Locations

1 site across 1 country: Italy