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NCT01237951 · ClinicalTrials.gov registry record · Phase 2
High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT01237951: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01237951 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01237951, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.
Primary Outcome
Stringent complete remission was defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 5% or fewer plasma cells in bone marrow, normal free light chain ratio, and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Interventions
- DRUG Melphalan
- DRUG Busulfan
- DRUG Dexamethasone
- DRUG Gemcitabine
- DRUG Palifermin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2010-11-08 |
| Est. Completion | 2017-09-20 |
| Phase | Phase 2 |
What the finished NCT01237951 record still lists
NCT01237951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT01237951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01237951 about?
NCT01237951 is a clinical study titled "High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma". The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.
What is the current status of trial NCT01237951?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2010-11-08. Estimated completion is 2017-09-20.
What interventions are being tested in trial NCT01237951?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), Dexamethasone (DRUG), Gemcitabine (DRUG), Palifermin (DRUG).
Who is sponsoring clinical trial NCT01237951?
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 NCT01237951's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 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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