Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361088
Status:
TERMINATED
Last Update Posted:
2013-11-25
First Post:
2006-08-03
Brief Title:
A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Dose Escalation of Zarnestra R115777 Combined With Velcade PS-341 in Patients With Relapsed Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Initial Principal Investigator left Moffitt
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Phase I patients will receive a combination of PS-341 Velcade and R115777 Zarnestra to determine the dose limiting toxicity DLT Once DLT is determined patients in Phase II will be receive the maximum tolerated dose MTD to complete 8 cycles of therapy Treatment will continue if there is evidence of continued response for 8 cycles Patients will receive follow up to include normal laboratory evaluations at least every 3 months and a skeletal survey will be performed at least every 6 months
Detailed Description:
In Phase I patients will receive intravenous PS-341 Velcade and 3 different dose levels of oral R115777 Zarnestra Dose Limiting Toxicity DLT will be determined over a period of one cycle and dose escalation to the next level will not occur until all patients projected at each level complete one cycle of therapy Once DLT is determined patients in Phase I and all patients enrolled for the phase II component will be treated at the maximum tolerated dose MTD to complete 8 cycles of therapy Treatment will continue beyond 8 cycles if there is evidence of continued response The study regimen will consist of two weeks of treatment followed by one week off for a total cycle duration of three weeks If disease stabilization occurs noted on 2 consecutive cycles after the standard 8 cycles are given treatment will be discontinued
Patients are to be monitored for adverse events throughout the treatment phases and for a minimum of 30 days after their last dose of drugs Follow up will include history and physical exam with laboratory evaluation at least every 3 months Laboratories will include CMP CBC SPEP UPEP and quantitative immunoglobulins A skeletal survey will be performed at least every 6 months
Patients are to be monitored for adverse events throughout the treatment phases and for a minimum of 30 days after their last dose of drugs Follow up will include history and physical exam with laboratory evaluation at least every 3 months Laboratories will include CMP CBC SPEP UPEP and quantitative immunoglobulins A skeletal survey will be performed at least every 6 months
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 |
|---|---|---|---|
| 7032 | OTHER | NCI | None |