NCT01464034

A Safety and Efficacy Study of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

A Multi-Center Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (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 pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy.

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 pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy. The study will explore the efficacy of CPD including overall response, time to progression, progression free survival, and time to next therapy.

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	Pomalidomide	PO daily on Days 1-21, every 28 Days
DRUG	Dexamethasone	40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.

Timeline

• Start date: 2011-11-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2011-11-03
• Last updated: 2022-08-01

Locations

9 sites across 1 country: United States