At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Carfilzomib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Dose Escalation Study of Carfilzomib in Patients With Previously-Treated Systemic Light-Chain (AL) Amyloidosis
In Brief
A Phase 1 clinical trial evaluating Carfilzomib and Dexamethasone for Amyloidosis and Systemic Light Chain Amyloidosis. Completed, enrolled 32 participants across 10 sites.
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyloidosis, Systemic Light Chain Amyloidosis
CountriesUnited States
CollaboratorsAmgen
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedFeb 2013
Primary CompletionDec 2016
Study CompletionJul 2017
TodayJul 2026
First PostedFeb 12, 2013
Enrollment StartFeb 1, 2013
Primary CompletionDec 1, 2016
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.4 years ago
Interventions
Carfilzomibdrug
IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 every 28 days.
Dexamethasonedrug
Dexamethasone IV or PO on Days 1, 2, 8, 9, 15, and 16 every 28 days in patients with \<VGPR after 4 cycles.