NCT02115035

A Single Agent Study to Evaluate the Overall Response Rate, Safety and Tolerability of Orally Administered Vemurafenib

A Phase II Single Agent Study to Evaluate the Overall Response Rate, Safety and Tolerability of Orally Administered Vemurafenib (VMRB) in Patients With Relapsed or Refractory Multiple Myeloma Who Have Activated BRAF Mutation

• Status: Withdrawn
• Phase: Phase 1 / 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 objective is to evaluate the overall response rate of Vermurafenib when administered orally to patients with relapsed or refractory multiple myeloma.

Detailed description

This is an open-label study to evaluate the objective response rates of orally administered Vermurafenib for patients with double refractory multiple myeloma. Double refractory multiple myeloma is myeloma that has become refractory to two chemotherapeutic agents such as bortexomib and lenalidomide. The study will be conducted in two stages with an interim data analysis performed after enrollment of the initial 21 subjects to determine whether the study will enroll an additional 20 subjects.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Vermurafenib	960 mg of Vermurafenib twice daily orally on a 28 day schedule

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2014-04-15
• Last updated: 2014-08-27

Locations

1 site across 1 country: United States