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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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