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Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

NCT01102426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2020-11-10

Study results available
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Summary

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

Conditions

Interventions

DRUG

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.

DRUG

Dexamethasone

4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Principal Investigators

  • Óscar F. Ballester, M.D. · Edwards Comprehensive Cancer Center, Marshall University (Huntington)

  • Rubén Niesvizky, M.D. · NY Presbyterian Hosp. - Cornell University - NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01102426 on ClinicalTrials.gov