Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 19 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01548573
The ClinicalTrials.gov registry entry for NCT01548573 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01548573 reports 0 study locations.
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
Explore more on PlainTrial
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.