Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240162
Status:
TERMINATED
Last Update Posted:
2014-09-17
First Post:
2005-10-13
Brief Title:
PTKZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase II Study of PTK787ZK 222584 a Novel Oral Angiogenesis Inhibitor as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma Following High Dose Chemotherapy and Autologous Stem Cell Transplant
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
investigator letter from drug manufacturer stating animal studies showed increased risk of cancer which was an unknown adverse event
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study it to evaluate the efficacy of PTK787ZK 222584 in inducing at least a 50 reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are 5 gdL following high dose chemotherapy HDCT and autologous stem cell transplantation ASCT
Detailed Description:
To evaluate the efficacy of PTK787ZK 222584 in inducing at least a 50 reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are 5 gdL following high dose chemotherapy HDCT and Autologous Stem Cell Transplantation ASCT
To assess the time to progression and disease free survival of patients treated with PTK787ZK 222584
To assess the safety and tolerability of PTK787ZK 222584 in multiple myeloma patients following ASCT
To assess the time to progression and disease free survival of patients treated with PTK787ZK 222584
To assess the safety and tolerability of PTK787ZK 222584 in multiple myeloma patients following ASCT
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 72721 | None | None | None |