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NCT01155583 · ClinicalTrials.gov registry record · Phase 1
Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01155583: Completed Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT01155583 is a Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01155583, a Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as azacitidine and dexamethasone, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving azacitidine together with lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when given together with lenalidomide and low-dose dexamethasone in treating patients with relapsed or refractory multiple myeloma.
Primary Outcome
Azacitidine given at low but increasing doses up to 50mg/m2 twice a week. Maximum tolerated dose reported.
Interventions
- DRUG azacitidine
- DRUG dexamethasone
- DRUG lenalidomide
- OTHER gene expression analysis
- OTHER DNA methylation analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-06 |
| Est. Completion | 2018-11-06 |
| Phase | Phase 1 |
What the finished NCT01155583 record still lists
NCT01155583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which azacitidine is the first listed.
NCT01155583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01155583 about?
NCT01155583 is a clinical study titled "Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma". RATIONALE: Drugs used in chemotherapy, such as azacitidine and dexamethasone, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and sto...
What is the current status of trial NCT01155583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2010-06. Estimated completion is 2018-11-06.
What interventions are being tested in trial NCT01155583?
The interventions under investigation include: azacitidine (DRUG), dexamethasone (DRUG), lenalidomide (DRUG), gene expression analysis (OTHER), DNA methylation analysis (OTHER).
Who is sponsoring clinical trial NCT01155583?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01155583's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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