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NCT01413178 · ClinicalTrials.gov registry record · Phase 3
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 205
- Enrollment target
NCT01413178: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT01413178 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 205 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01413178, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 205 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied. Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.
Primary Outcome
Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.
Interventions
- DRUG Melphalan
- DRUG Busulfan
- DRUG G-CSF
- OTHER Questionnaire
- DRUG High Dose Melphalan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2011-09-30 |
| Est. Completion | 2019-03-10 |
| Phase | Phase 3 |
What the finished NCT01413178 record still lists
NCT01413178 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT01413178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01413178 about?
NCT01413178 is a clinical study titled "A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma". The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be stud...
What is the current status of trial NCT01413178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 205 participants. The study started on 2011-09-30. Estimated completion is 2019-03-10.
What interventions are being tested in trial NCT01413178?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), G-CSF (DRUG), Questionnaire (OTHER), High Dose Melphalan (DRUG).
Who is sponsoring clinical trial NCT01413178?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01413178's enrollment target sits among peer trials
205 1350th of 2000 higher than 649 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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