Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 2 study, sponsored by University of Miami.
NCT01965834 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.
Interventions
- DRUG Fenofibrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-11-19 |
| Est. Completion | 2016-07-01 |
| Phase | Phase 2 |
Why NCT01965834 stopped before completion
NCT01965834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Fenofibrate is the first listed.
NCT01965834 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01965834's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI