Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2026-03-12 @ 9:21 AM
Study NCT ID:
NCT00530816
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2007-09-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the best overall response rate, safety and tolerability of carfilzomib in patients with relapsed or refractory multiple myeloma.
Detailed Description:
Two groups of patients with multiple myeloma were initially studied: bortezomib-naïve and bortezomib-treated. Following Amendment 2, only bortezomib-naïve patients were enrolled. Study results were reported in 2 parts, depending on whether a patient received prior bortezomib.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: