NCT01660750

A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma

A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to ASCT in Patients With Transplant Eligible Newly Diagnosed Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Criterium, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma.

Detailed description

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma. The study will also explore the efficacy of Car-Cy-Dex including overall response after induction therapy, overall response at 3 and 6 months post ASCT, and time to progression, progression free survival, and time to next therapy if it occurs within 6 months post ASCT.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
DRUG	Cyclophosphamide	PO on days 1, 8, and 15 every 28 days
DRUG	Dexamethasone	40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2012-08-09
• Last updated: 2017-10-18

Locations

5 sites across 1 country: United States