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NCT04521335 · ClinicalTrials.gov registry record · Phase 1
Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma
A Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04521335 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 2 participants.
The verdict
NCT04521335, a Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a phase I, open-label trial of disulfiram in combination with copper gluconate in patients with treatment-refractory multiple myeloma. The trial is designed to assess the Phase 2 Recommended Dose (RP2D) of disulfiram and copper gluconate in combination. The trial will open with dose escalation, followed to an expansion cohort to further characterize the safety and tolerance of the combination. Dose escalation will utilize a standard 3+3 design and will test up to five dose levels. Dose levels will be separated into two sequential parts defined by the fixed dose of copper as copper gluconate administered with ascending doses of disulfiram. Part 1 of dose escalation will consist of dose levels 0 and 1 with the option to reduce to Dose Level -1 if Dose Level 0 is deemed intolerable. Part 2 will test dose levels 2 and 3. The Dose Level deemed to be the RP2D will be used in dose expansion.
Interventions
- DRUG Disulfiram
- DRUG Copper Gluconate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2022-02-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04521335
The ClinicalTrials.gov registry entry for NCT04521335 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Disulfiram is the first listed.
NCT04521335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04521335 about?
NCT04521335 is a clinical study titled "Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma". This is a phase I, open-label trial of disulfiram in combination with copper gluconate in patients with treatment-refractory multiple myeloma. The trial is designed to assess the Phase 2 Recommended Dose (RP2D) of disulfiram and copper gluconate in combination. The trial will open with dose escalati...
What is the current status of trial NCT04521335?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-05-21. Estimated completion is 2022-02-06.
What interventions are being tested in trial NCT04521335?
The interventions under investigation include: Disulfiram (DRUG), Copper Gluconate (DRUG).
Who is sponsoring clinical trial NCT04521335?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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