Multiple Myeloma Clinical Trial
Official 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
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.
STUDY OBJECTIVES
Primary objective:
• Determine antitumor activity of ultrahigh dose dexamethasone (UHDD) as monotherapy in
relapsed multiple myeloma.
Secondary objectives:
- Characterize the safety and tolerability of UHDD as monotherapy in patients with
relapsed multiple myeloma.
- Determine the progression free survival amongst responders.
- Determine the subset of patients in whom UHDD can be used as monotherapy for treatment
of relapsed multiple myeloma
STUDY ENDPOINTS
Primary endpoint: To determine the anti-tumor activity of UHDD as monotherapy in patients
with relapsed multiple myeloma as measured by the International Myeloma Working Group (IMWG)
response criteria:
- Change from baseline in M protein component.
- Objective response rate (complete response [CR] + partial response [PR]) assessed
according to IMWG response criteria.
- Disease control rate (CR+PR+stable disease [SD]).
Secondary endpoints:
- Safety and tolerability of UHDD
- Progression free survival.
- Characteristics of patients responding to UHDD.
;
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