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NCT01807286 · ClinicalTrials.gov registry record · Phase 1
Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01807286: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01807286 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807286, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given in combination with melphalan and dexamethasone that can be given to patients with AL amyloidosis. The safety of this drug combination will also be studied. Pomalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Melphalan is designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to Multiple Myeloma (MM) patients in combination with other chemotherapy to treat cancer. Planned Phase I/II Study terminated early during Phase I portion without continuation to Phase II.
Primary Outcome
Maximum tolerated dose defined as highest dose level at which less than 33% of patients experienced dose-limiting toxicities. Dose-limiting toxicities defined as (grade 4 neutropenia lasting more than 7 days despite G-CSF administration, any other grade 4 hematologic toxicity, any grade 3 non-hematologic toxicity, or a new cycle delay beyond a maximum of 4 weeks) in less than 33% of patients during the first cycle of therapy.
Interventions
- DRUG Melphalan
- DRUG Dexamethasone
- BEHAVIORAL Questionnaires
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
Why NCT01807286 stopped before completion
NCT01807286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Melphalan is the first listed.
NCT01807286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01807286 about?
NCT01807286 is a clinical study titled "Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis". The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given in combination with melphalan and dexamethasone that can be given to patients with AL amyloidosis. The safety of this drug combination will also be studied. Pomalidomide is designed to c...
What is the current status of trial NCT01807286?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01807286?
The interventions under investigation include: Melphalan (DRUG), Dexamethasone (DRUG), Questionnaires (BEHAVIORAL), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01807286?
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 NCT01807286's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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