Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT02115035
Status:
WITHDRAWN
Last Update Posted:
2014-08-27
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Agent Study to Evaluate the Overall Response Rate, Safety and Tolerability of Orally Administered Vemurafenib
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: