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NCT01215344 · ClinicalTrials.gov registry record · Phase 2
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01215344: Completed Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01215344 is a Phase 2 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215344, a Phase 2 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant. Our hypothesis is that MRD-status will continue to increase significantly at 3 months post-transplant and will validate that HDC and ASCT needs to be performed even when patients have achieved major response after induction therapy with novel agents.
Primary Outcome
Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG VELCADE
- DRUG DVT prophylaxis
- DRUG Bisphosphonates
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-11 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
What the finished NCT01215344 record still lists
NCT01215344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT01215344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01215344 about?
NCT01215344 is a clinical study titled "First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade". The purpose of this study is to study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant...
What is the current status of trial NCT01215344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-11. Estimated completion is 2018-03.
What interventions are being tested in trial NCT01215344?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), VELCADE (DRUG), DVT prophylaxis (DRUG), Bisphosphonates (DRUG).
Who is sponsoring clinical trial NCT01215344?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01215344's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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