CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Bendamustine +1 moredrug
Likely dose
Bendamustine 60 mLfrom 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.

Search/NCT01222260
NCT01222260Phase 2Completed
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Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

Columbia University·interventional·Posted Oct 18, 2010·Updated Mar 30, 2020

In Brief

A Phase 2 clinical trial evaluating Bendamustine and Dexamethasone for AL Amyloidosis. Completed, enrolled 40 participants across 6 sites.

Detailed Summary

The study is being done to see if the combination of bendamustine and dexamethasone will help people with amyloidosis that has returned after standard treatment, and to to estimate the partial hematologic response rate (PHR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAL Amyloidosis
CountriesUnited States
CollaboratorsCephalon

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2010
Enrollment StartJan 1, 2013
Primary CompletionMar 1, 2019
Study CompletionJul 3, 2019
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 15.7 years ago

Interventions

Bendamustinedrug

Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle: * CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle * CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle Available to qualifying subjects is the option to dose escalate to dose level (+)1: * 120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study) * 100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)

Dexamethasonedrug

40 mg orally on days 1, 8, 15, 22 of each cycle