NCT02402725

A Open-label Study of Ultra-High Dose Dexamethasone for Relapsed Multiple Myeloma

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Dexamethasone	(1 cycle = 28 days) D1: Dexamethasone 100mg IV; Dex 24mg PO every 6 hrs (begin immediately after IV dex) D2: Dex 24mg PO every 6 hrs D3: Dex 24mg PO every 6 hrs

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-03-30
• Last updated: 2017-02-15

Locations

1 site across 1 country: United States