NCT02578121

UARK 2015-03 A Phase II Trial of a Novel Proteasome/IMiD Combination

A Phase II Trial of a Novel Proteasome/IMiD Combination, Ixazomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma Patients

• Status: Withdrawn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

Summary

The purpose of this study is to determine the efficacy of Ixazomib when combined with Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed Multiple Myeloma

Detailed description

This single arm, Phase II study will examine the efficacy and safety of the novel Proteasome/IMiD combination of Ixazomib 4mg days 1, 8, 15, Pomalidomide 4 mg days 1-21, Dexamethasone 20 mg days 1, 8, 15, and 22 of a 28 day cycle, in relapse patients. The long term aim being to develop a backbone regimen to which future novel targeted treatments may be added as part of a personalized medicine approach.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle
DRUG	Pomalidomide	4.0 mg will be given on days 1-21 of a 28 day cycle
DRUG	Dexamethasone	20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-10-16
• Last updated: 2017-01-23

Locations

1 site across 1 country: United States