A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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."|
- Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response [ Time Frame: Every 2 weeks until progression or death occurs. ] [ Designated as safety issue: No ]
- Time to Progression (TTP) [ Time Frame: Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed. ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS) [ Time Frame: Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed. ] [ Designated as safety issue: No ]
- Number of Patients With Overall Survival (OS) [ Time Frame: Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed. ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229203
|United States, Massachusetts|
|Jerome Lipper Multiple Myeloma Center - Dept of Medical Oncology - Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Paul Richardson, MD||Chief division hematological malignancies - Medical Oncology - Dana Farber Cancer Institute - Harvard Medical School, Boston|