Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229203
Status:
COMPLETED
Last Update Posted:
2009-12-24
First Post:
2005-09-27
Brief Title:
A Study of Aplidin Plitidepsin 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma
Sponsor:
PharmaMar
Organization:
PharmaMar
Study Overview
Official Title:
Phase II Multicenter Open-Label Clinical and Pharmacokinetic Study of Aplidin As A 3-Hour Infusion Every 2 Weeks Alone or in Combination With Dexamethasone in Pre-Treated Patients With Relapsing or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2009-12
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:
This is a phase II study to determine the efficacy following treatment with Aplidin 5 mgm2 given as a 3 hours intravenous infusion every 2 weeks in patients with relapsed or refractory multiple myeloma MM
Detailed Description:
This is a phase II study to determine the efficacy following treatment with Aplidin 5 mgm2 given as a 3 h iv infusion every 2 weeks in patients with relapsed or refractory multiple myeloma MM and to obtain the following
Additional pharmacokinetic information for Aplidin given as 3-hour IV infusion every 2 weeks in patients with MM
To obtain additional genomic and pharmacodynamics information on MM and Aplidin
To assess the safety and tolerability of Aplidin given as 3-hour IV infusion every 2 weeks in patients with MM alone or in combination with dexamethasone given orally as a 20 mg daily for 4 days
To determine the response rate in the second cohort of patients following treatment with Aplidin given as a 3 hour infusion every 2 weeks plus dexamethasone given orally as a 20 mg daily for 4 days starting the same day of Aplidin administration as a second treatment stage in patients with suboptimal response to Aplidin as single agent progressive disease after three cycles or stable disease after four cycles
Additional pharmacokinetic information for Aplidin given as 3-hour IV infusion every 2 weeks in patients with MM
To obtain additional genomic and pharmacodynamics information on MM and Aplidin
To assess the safety and tolerability of Aplidin given as 3-hour IV infusion every 2 weeks in patients with MM alone or in combination with dexamethasone given orally as a 20 mg daily for 4 days
To determine the response rate in the second cohort of patients following treatment with Aplidin given as a 3 hour infusion every 2 weeks plus dexamethasone given orally as a 20 mg daily for 4 days starting the same day of Aplidin administration as a second treatment stage in patients with suboptimal response to Aplidin as single agent progressive disease after three cycles or stable disease after four cycles
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