NCT01792102

Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma

A Phase 1/2 Study of Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Patients With Progressive Multiple Myeloma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Oncotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma.

Detailed description

This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma. The study will consist of a screening period, followed by a treatment period of up to eight 28-day treatment cycles, followed by a period of maintenance treatment. Subjects are to be treated until disease progression.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib and Dexamethasone	Phase 1: Carfilzomib will be administered at an escalating dose by cohort as 60-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. On Cycle 1 Days 1 and 2, carfilzomib will be given at 20 mg/m\^2. For all subsequent doses, carfilzomib will be administered at the dose assigned to the cohort (56, 70, or 88 mg/m\^2). Dexamethasone (8 mg IV or PO) will be administered prior to carfilzomib on Days 1, 2, 8, 9, 15, and 16. Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: From Cycle 9 onward, carfilzomib and dexamethasone will be administered in the same fashion as during the previous treatment cycle, but only on days 1, 2, 15, and 16.

Timeline

• Start date: 2013-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2013-02-15
• Last updated: 2018-03-05

Locations

2 sites across 1 country: United States