Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma
Summary
Third Opinion Trial Synopsis:
This is a study to find out if combining disulfiram and copper gluconate can help treat patients with multiple myeloma that has not responded to other treatments. The study will start with a small amount of both medicines and slowly increase the amount to see what is safe and works best. The goal is to find the right amount to use for future treatments. The study will test up to five different amounts of the medicines. The amount that works best will then be used to study if it is safe and can help more patients.
This is a study to find out if combining disulfiram and copper gluconate can help treat patients with multiple myeloma that has not responded to other treatments. The study will start with a small amount of both medicines and slowly increase the amount to see what is safe and works best. The goal is to find the right amount to use for future treatments. The study will test up to five different amounts of the medicines. The amount that works best will then be used to study if it is safe and can help more patients.
*Third Opinion AI Generated Synopsis
Trial 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.
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.
Locations & Contact
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