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NCT01965834 · ClinicalTrials.gov registry record · Phase 2
Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma
A Phase 2 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01965834 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 6 participants.
The verdict
NCT01965834, a Phase 2 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Multiple myeloma cells are dependent on calcium (Ca2+) for their function. Specifically, Ca2+ is required for the function of the endoplasmic reticulum in which proteins, including immunoglobulins, are folded prior to their release from the cell. Multiple myeloma cells secrete large concentrations of immunoglobulins continuously and as result depend on mitochondria activity to replenish the Ca2+ levels in the endoplasmic reticulum as was shown in vitro in our lab. Fenofibrate has been shown to inhibit mitochondrial function resulting in inhibition of protein folding in the endoplasmic reticulum of multiple myeloma (MM) cells that leads to the induction of a stress signal known as the unfolded protein response and subsequently apoptosis. The effective anti-myeloma concentrations for fenofibrate are attainable in the clinical setting as they are in the same range as the effective concentrations for anti-hyperlipidemic effect. The investigators propose to evaluate fenofibrate therapy in multiple myeloma patients.
Interventions
- DRUG Fenofibrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-11-19 |
| Est. Completion | 2016-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01965834
The ClinicalTrials.gov registry entry for NCT01965834 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fenofibrate is the first listed.
NCT01965834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01965834 about?
NCT01965834 is a clinical study titled "Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma". Multiple myeloma cells are dependent on calcium (Ca2+) for their function. Specifically, Ca2+ is required for the function of the endoplasmic reticulum in which proteins, including immunoglobulins, are folded prior to their release from the cell. Multiple myeloma cells secrete large concentrations o...
What is the current status of trial NCT01965834?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-11-19. Estimated completion is 2016-07-01.
What interventions are being tested in trial NCT01965834?
The interventions under investigation include: Fenofibrate (DRUG).
Who is sponsoring clinical trial NCT01965834?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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