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NCT01079936 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and High-Dose Melphalan
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01079936: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01079936 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01079936, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of Revlimid (lenalidomide) and high-dose Alkeran (melphalan) that can be given to patients with multiple myeloma who will receive an autologous stem cell transplantation. The safety of this combination therapy will also be studied.
Primary Outcome
There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30
Interventions
- DRUG Melphalan
- DRUG Lenalidomide
- PROCEDURE Stem Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT01079936 record still lists
NCT01079936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Melphalan is the first listed.
NCT01079936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01079936 about?
NCT01079936 is a clinical study titled "Lenalidomide and High-Dose Melphalan". The goal of this clinical research study is to find the highest tolerable dose of the combination of Revlimid (lenalidomide) and high-dose Alkeran (melphalan) that can be given to patients with multiple myeloma who will receive an autologous stem cell transplantation. The safety of this combination ...
What is the current status of trial NCT01079936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2010-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01079936?
The interventions under investigation include: Melphalan (DRUG), Lenalidomide (DRUG), Stem Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01079936?
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 NCT01079936's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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