At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
Ixazomib +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.
An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Formulation of MLN9708 Administered Weekly in Adult Patients With Relapsed or Refractory Light-Chain (AL) Amyloidosis Who Require Further Treatment
In Brief
A Phase 1 clinical trial evaluating Ixazomib and Dexamethasone for Light-Chain Amyloidosis. Completed, enrolled 27 participants across 10 sites in 5 countries.
Detailed Summary
This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLight-Chain Amyloidosis
CountriesCanada, France, Germany, Italy, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartApr 2011
Primary CompletionNov 2018
TodayJul 2026
First PostedMar 21, 2011
Enrollment StartApr 27, 2011
Primary CompletionNov 13, 2018
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 15.3 years ago
Interventions
Ixazomibdrug
Ixazomib capsules.
Dexamethasonedrug
Dexamethasone tablets.