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NCT01985477 · ClinicalTrials.gov registry record · Phase 1
Revlimid / All-Trans Retinoic Acid (ATRA) / Dexamethasone in Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01985477: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01985477 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01985477, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The goal of the Phase I portion of this clinical research study is to find the highest tolerated dose of the combination of lenalidomide, all-trans retinoic acid (ATRA), and dexamethasone that can be given to patients with relapsed or refractory multiple myeloma (MM). The goal of the Phase II portion of this study is to learn if ATRA when given in combination with lenalidomide alone or with lenalidomide and dexamethasone can help to control multiple myeloma. In September 2015, the study was terminated due to slow accrual while still a Phase I study, no additional registration or research performed under the Phase II portion of the study.
Primary Outcome
MTD defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose limiting toxicity refers to a medically significant event which meets one of the following: Hematologic dose-limiting toxicity defined as either, Grade 4 neutropenia lasting for \>/=14 days in duration ( growth factors permitted after DLT established), Grade 4 thrombocytopenia \> 14 days despite platelet transfusions. Non-hematologic DLT defined as any Grade
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG All-Trans Retinoic Acid (ATRA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
Why NCT01985477 stopped before completion
NCT01985477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01985477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01985477 about?
NCT01985477 is a clinical study titled "Revlimid / All-Trans Retinoic Acid (ATRA) / Dexamethasone in Relapsed/Refractory Multiple Myeloma". The goal of the Phase I portion of this clinical research study is to find the highest tolerated dose of the combination of lenalidomide, all-trans retinoic acid (ATRA), and dexamethasone that can be given to patients with relapsed or refractory multiple myeloma (MM). The goal of the Phase II porti...
What is the current status of trial NCT01985477?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2013-12. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01985477?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), All-Trans Retinoic Acid (ATRA) (DRUG).
Who is sponsoring clinical trial NCT01985477?
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 NCT01985477's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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