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NCT01537861 · ClinicalTrials.gov registry record · Early Phase 1
Filgrastim in Treating Patients With Bortezomib-, Carfilzomib-, or IMID-Refractory Multiple Myeloma
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT01537861: Clinical Trial Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT01537861 is a Early Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 7 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537861, a Early Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in patients with multiple myeloma will generate a 'hostile' bone marrow microenvironment for myeloma cells, depriving them of key support signals and rendering them more sensitive to chemotherapy. The investigators therefore propose to do an initial pilot study 1) to explore the safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment regimens in patients with bortezomib-, carfilzomib-, or IMID-refractory myeloma and 2) to generate correlative data for a subsequent larger study looking at the combination.
Primary Outcome
Number and grade of adverse events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Carfilzomib
- DRUG Bortezomib
- DRUG Filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-12 |
| Phase | Early Phase 1 |
Why NCT01537861 stopped before completion
NCT01537861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01537861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01537861 about?
NCT01537861 is a clinical study titled "Filgrastim in Treating Patients With Bortezomib-, Carfilzomib-, or IMID-Refractory Multiple Myeloma". Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in patients with multiple myeloma will generate a 'hostile' bone marrow microenvironment for myeloma cells, depriving them of key support signals and rendering them more sensitive to chemotherapy. The investigators the...
What is the current status of trial NCT01537861?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2012-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01537861?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Carfilzomib (DRUG), Bortezomib (DRUG), Filgrastim (DRUG).
Who is sponsoring clinical trial NCT01537861?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537861's enrollment target sits among peer trials
7 1825th of 2000 higher than 156 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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