Clinical Trial: A Safety Study of Carfilzomib in Patients With Previously-Treated Systemic Light Chain Amyloidosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase I Dose Escalation Study of Carfilzomib in Patients With Previously-Treated Systemic Light-Chain (AL) Amyloidosis
Brief 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 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. 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.
Sponsor: Academic Myeloma Consortium
Current Primary Outcome: Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Throughout treatment, estimated at 8 months per patient ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Hematologic Response [ Time Frame: Every 28 days while on treatment (estimated at 8 months per patient) ]Hematologic Response Rates (PR, VGPR, and CR
- Organ Response [ Time Frame: Every 112 days while on treatment (estimated at 8 months per patient) ]Organ response rates by standard criteria
- Progression Free Survival [ Time Frame: throughout study and follow up (every 2-3 months for 2 years ]
- Time to next therapy [ Time Frame: throughout follow up (every 2-3 months for 2 years) ]
Original Secondary Outcome: Same as current
Information By: Academic Myeloma Consortium
Dates:
Date Received: February 6, 2013
Date Started: February 2013
Date Completion: July 2018
Last Updated: July 12, 2016
Last Verified: July 2016