NCT00603447

Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma

Phase 1b Multicenter Dose Escalation Study of Carfilzomib With Lenalidomide and Dexamethasone for Safety and Activity in Relapsed Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma

Conditions

• Relapsed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Carfilzomib for Injection was administered intravenously over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for the first 12 cycles. Each dose of Carfilzomib for Injection was normalized to body surface area.
DRUG	Lenalidomide	Lenalidomide was administered orally on Days 1 to 21 of each 28-day cycle.
DRUG	Dexamethasone	Dexamethasone 40 mg orally or intravenous equivalent was administered 30 minutes to 4 hours before carfilzomib on Days 1, 8, and 15, as well as on Day 22 of each 28-day cycle.

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-05-01
• Completion: 2016-01-01
• First posted: 2008-01-29
• Last updated: 2017-05-30
• Results posted: 2015-06-03

Locations

12 sites across 2 countries: United States, Canada