A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00229203|
Recruitment Status : Completed
First Posted : September 29, 2005
Results First Posted : December 14, 2009
Last Update Posted : December 24, 2009
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Plitidepsin||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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."|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
- Drug: Plitidepsin
3-hour infusion every 2 weeks alone or in combination with dexamethasone
- 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. ]
Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: >25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.
Treatmen failure: Reappearance of serum or urinary paraprotein
- 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. ]Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as >25 percentage increase in level of serum monoclonal paraprotein.
- 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. ]Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death
- 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. ]Overall Survival (OS): time from the date of first infusion to the date of documented death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|