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NCT01548573 · ClinicalTrials.gov registry record · Phase 2
Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment
A Phase 2 study, sponsored by University of Iowa.
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01548573: Clinical Trial Phase 2 study, sponsored by University of Iowa.
NCT01548573 is a Phase 2 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01548573, a Phase 2 study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study is designed to decrease toxicity associated with prior tandem transplant protocols by reducing the intensity of induction, consolidation and maintenance therapy, while increasing event-free survival by adding bortezomib (Velcade®), thalidomide, gemcitabine and carmustine to the transplant regimens to down-regulate the rescue of myeloma cells by the micro-environment and to prevent DNA repair post high-dose alkylating agent therapy. By reducing drug resistance, it is hoped that 3-year event-free survival will be increased significantly when compared to Total Therapy II. Additionally, participants will have the option of providing biospecimens for a sub-study evaluating gene expression profiling at specific timepoints to better understand drug-resistance in myeloma, and to determine whether there are genes or gene products in the resistant population that can be targeted by novel therapies.
Primary Outcome
To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.
Interventions
- DRUG Cyclophosphamide
- DRUG Cisplatin
- DRUG Doxorubicin
- DRUG Dexamethasone
- PROCEDURE Tandem autologous stem cell transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
Why NCT01548573 stopped before completion
NCT01548573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01548573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01548573 about?
NCT01548573 is a clinical study titled "Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment". This study is designed to decrease toxicity associated with prior tandem transplant protocols by reducing the intensity of induction, consolidation and maintenance therapy, while increasing event-free survival by adding bortezomib (Velcade®), thalidomide, gemcitabine and carmustine to the transplant...
What is the current status of trial NCT01548573?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2012-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01548573?
The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Doxorubicin (DRUG), Dexamethasone (DRUG), Tandem autologous stem cell transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01548573?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01548573's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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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