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NCT01222260 · ClinicalTrials.gov registry record · Phase 2
Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis
A Phase 2 study of AL Amyloidosis, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 6
- Study locations
NCT01222260: Completed Phase 2 study of AL Amyloidosis, sponsored by Columbia University.
NCT01222260 is a Phase 2 study of AL Amyloidosis that has completed, run by Columbia University. The registered enrollment target is 40 participants, below the 422-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222260, a Phase 2 study of AL Amyloidosis, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 6
- Study locations
Study 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).
Primary Outcome
Only patients who have received at least 2 cycles of therapy are eligible for response assessment. The proportion of patients with PHR two months post-treatment will be estimated, with a 95% exact binomial confidence interval. Partial response is defined as the reduction of the difference between involved and uninvolved free light chains (dFLC) of ≥ 50% OR a reduction of ≥ 50% of the M-protein if M-spike is ≥ 0.5 g/dL.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Bendamustine
Study Locations (6)
New York
- Mt. Sinai Medical Center - New York
- Columbia University - New York
- Memorial Sloan-Kettering Cancer Center - New York
Massachusetts
- Tufts Medical Center - Boston
- Boston Medical Center - Boston
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-01 |
| Est. Completion | 2019-07-03 |
| Phase | Phase 2 |
What the finished NCT01222260 record still lists
NCT01222260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 422-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (91% lower).
The record links to 1 condition, with AL Amyloidosis appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01222260 lists 6 locations in 3 states (New York, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT01222260 about?
NCT01222260 is a clinical study titled "Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis". 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).
What is the current status of trial NCT01222260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-01. Estimated completion is 2019-07-03.
What conditions does trial NCT01222260 study?
This clinical trial studies the following conditions: AL Amyloidosis.
What interventions are being tested in trial NCT01222260?
The interventions under investigation include: Dexamethasone (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01222260?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01222260 being conducted?
This trial has 6 study locations across Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for AL Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01222260's enrollment target sits among peer trials
40 9th of 15 higher than 7 of 15 other AL Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AL Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
RECRUITING · Phase 2
-
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
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Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
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Ixazomib Maintenance Study in Patients With AL Amyloidosis
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Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
RECRUITING
-
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
RECRUITING · Phase 1
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