Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01083316 · ClinicalTrials.gov registry record · Phase 2
Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis
A Phase 2 study of Amyloidosis, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01083316: Completed Phase 2 study of Amyloidosis, sponsored by Boston Medical Center.
NCT01083316 is a Phase 2 study of Amyloidosis that has completed, run by Boston Medical Center. The registered enrollment target is 35 participants, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01083316, a Phase 2 study of Amyloidosis, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
The drugs dexamethasone and bortezomib are both FDA-approved for the treatment of multiple myeloma, a disease very similar to amyloidosis. However, they are currently investigational for the treatment of amyloidosis. We want to find out if the addition of dexamethasone and bortezomib to standard high dose chemotherapy and stem cell transplant can help improve response. Standard treatment includes four steps: 1) Stem Cell Mobilization (standard) 2) Stem Cell Collection (standard) 3) Conditioning Regimen (Melphalan chemotherapy). The conditioning regimen helps to kill the abnormal cells in the body and makes room in the bone marrow for new blood stem cells to grow. 4) Stem Cell Infusion Participants in this study will have an additional treatment step called "induction therapy", designed as the first step towards reducing the number of abnormal cells in the body. Two cycles of the investigational drugs bortezomib and dexamethasone will be given during induction therapy. In addition, bortezomib will given as part of the conditioning regimen, in addition to the standard melphalan chemotherapy.
Primary Outcome
Complete response: Normal serum free light chain ratio and Negative serum and urine immunofixation electrophoresis Very good partial response: Difference in serum free light chains less than 40 mg/L Partial Response: \>50% Reduction in the difference in serum free light chains
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Dexamethasone
- DRUG Bortezomib
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2009-09 |
| Est. Completion | 2020-09-04 |
| Phase | Phase 2 |
What the finished NCT01083316 record still lists
NCT01083316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Amyloidosis appearing as the primary indexed condition, and to 3 interventions - of which Melphalan is the first listed.
NCT01083316 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01083316 about?
NCT01083316 is a clinical study titled "Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis". The drugs dexamethasone and bortezomib are both FDA-approved for the treatment of multiple myeloma, a disease very similar to amyloidosis. However, they are currently investigational for the treatment of amyloidosis. We want to find out if the addition of dexamethasone and bortezomib to standard hi...
What is the current status of trial NCT01083316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2009-09. Estimated completion is 2020-09-04.
What conditions does trial NCT01083316 study?
This clinical trial studies the following conditions: Amyloidosis.
What interventions are being tested in trial NCT01083316?
The interventions under investigation include: Melphalan (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT01083316?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01083316 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT01083316's enrollment target sits among peer trials
35 22nd of 28 higher than 7 of 28 other Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
-
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
RECRUITING · Phase 2
-
Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia (MILESTONE)
RECRUITING · Phase 2
-
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
RECRUITING · Phase 2
-
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
ACTIVE NOT RECRUITING · Phase 2
-
Ixazomib Rollover Study
COMPLETED · Phase 2
-
Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01697371 · 35 participants · NA
Proton Therapy in the Treatment of Liver Metastases
- NCT01940757 · 35 participants · Phase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
- NCT02235857 · 35 participants · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
- NCT02637934 · 35 participants · Phase 1
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia