Overview

This trial is active, not recruiting.

Condition relapsed/refractory multiple myeloma
Treatments plitidepsin + dexamethasone, dexamethasone
Phase phase 3
Sponsor PharmaMar
Start date June 2010
End date May 2017
Trial size 250 participants
Trial identifier NCT01102426, APL-C-001-09

Summary

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

United States California
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone APLIDIN (plitidepsin)
plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
(Active Comparator)
dexamethasone single agent
dexamethasone
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

Primary Outcomes

Measure
Progression Free Survival (PFS) as per intention-to-treat (ITT)
time frame: Estimated average: 5 months. From randomization to the first evidence of progressive disease or death due to any cause

Secondary Outcomes

Measure
Response rate
time frame: Every 4 weeks untill progression
Duration of Response
time frame: Estimated average: 3 months. From the date of first documentation of response to the date of disease progression or death.
Overall Survival
time frame: Estimated average: 9 months. From randomization to the first evidence of progressive disease or death due to any cause

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age ≥ 18 years. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 - Life expectancy ≥ 3 months. - Patients previously diagnosed with multiple myeloma - Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen. - Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available) - Women must have a negative serum pregnancy test - Voluntarily signed and dated written informed consent Exclusion Criteria: - Concomitant diseases/conditions - Women who are pregnant or breast feeding. - Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM - Known hypersensitivity to any involved study drug or any of its formulation components

Additional Information

Official title Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
Principal investigator Óscar F. Ballester, M.D.
Description Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by PharmaMar.