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Your journey
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More info
You can access this
clinical trial
if you have
Multiple Myeloma
and you are
over 18
years old
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

This is a phase II, open label, single-center study of ultra-high dose dexamethasone administered intravenously and orally as monotherapy for the treatment of relapsed multiple myeloma. Dexamethasone has known anti-myeloma activity, and has been studied extensively both alone, and in combination with other agents, in the treatment of multiple myeloma. This study implements an optimal 2-stage design. In Stage 1, 10 patients will be enrolled. Each patient will receive 100mg of intravenous dexamethasone once on Day 1, immediately followed by 24mg of oral (PO) dexamethasone every 6 hours for 3 days (Days 1-3) in a 28-day cycle. After 4 cycles, the patients will be evaluated for efficacy and safety. If 2 or more of the original 10 patients experience a CR, very good partial response (VGPR), or PR, an additional 20 patients will be enrolled in Stage 2. The enrollment for Stage 2 will occur after the completion of 4 cycles of ultra-high dose dexamethasone. If <2 patients experience a CR, VGPR, or PR, the study will be discontinued. Patients will be treated until progression, intolerable side effects, or death. The purpose of the proposed phase II study is to determine the overall response rate, progression free survival, and tolerability of "ultra-high" dose dexamethasone.

Provided treatments

  • Drug: Dexamethasone
Tris trial is registered with FDA with number: NCT02402725. The sponsor of the trial is Boston Medical Center and it is looking for 0 volunteers for the current phase.
Official trial title:
A Phase II, Open-label, Single Center Study of Ultra-High Dose Dexamethasone (UHDD) Administered Intravenously and Orally as Monotherapy for the Treatment of Relapsed Multiple Myeloma