A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma

Phase 2

Completed

Brief Summary: This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, 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 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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Overall Survival (OS)	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
Time to Progression (TTP)	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)	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

Locations (1): Jerome Lipper Multiple Myeloma Center - Dept of Medical Oncology - Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States