At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
daratumumabdrug
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-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis
In Brief
A Phase 2 clinical trial evaluating daratumumab for AL Amyloidosis. Completed, enrolled 22 participants across 1 site.
Detailed Summary
Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAL Amyloidosis
CountriesUnited States
CollaboratorsJanssen Pharmaceuticals
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartMar 2017
Primary CompletionMay 2020
Study CompletionJul 2020
TodayJul 2026
First PostedJul 21, 2016
Enrollment StartMar 20, 2017
Primary CompletionMay 28, 2020
Study CompletionJul 17, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.9 years ago
Interventions
daratumumabdrug
Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression or inability to tolerate.