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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01083316
The ClinicalTrials.gov registry entry for NCT01083316 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (97% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.