NCT01789242

A Safety Study of Carfilzomib in Patients With Previously-Treated Systemic Light Chain Amyloidosis

A Phase I Dose Escalation Study of Carfilzomib in Patients With Previously-Treated Systemic Light-Chain (AL) Amyloidosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Criterium, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose finding study to evaluate the safety and determine the maximum tolerated dose of carfilzomib in patients with previously treated systemic light-chain amyloidosis.

Detailed description

This is a dose finding study to evaluate the safety and determine the maximum tolerated dose of carfilzomib in patients with previously treated systemic light-chain amyloidosis. The study will also explore the efficacy of carfilzomib in both proteasome inhibitor-naive and proteasome inhibitor-exposed patients including hematologic response, organ response, progression free survival, and time to next therapy.

Conditions

• Amyloidosis
• Systemic Light Chain Amyloidosis

Interventions

Type	Name	Description
DRUG	Carfilzomib	IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 every 28 days.
DRUG	Dexamethasone	Dexamethasone IV or PO on Days 1, 2, 8, 9, 15, and 16 every 28 days in patients with \<VGPR after 4 cycles.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-12-01
• Completion: 2017-07-01
• First posted: 2013-02-12
• Last updated: 2017-10-18

Locations

10 sites across 1 country: United States