Aplidin - Dexamethasone in Relapsed/Refractory Myeloma (ADMYRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT01102426
First received: March 31, 2010
Last updated: July 3, 2014
Last verified: July 2014

March 31, 2010
July 3, 2014
June 2010
December 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM).
Same as current
Complete list of historical versions of study NCT01102426 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: Every 4 weeks untill progression ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Estimated average: 9 months. From randomization to the first evidence of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
    Overal Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Same as current
Not Provided
Not Provided
 
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma

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

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsed/Refractory Multiple Myeloma
  • Drug: plitidepsin + dexamethasone
    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.
    Other Name: APLIDIN (plitidepsin)
  • Drug: dexamethasone
    4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
  • Experimental: Arm A
    plitidepsin + dexamethasone combination
    Intervention: Drug: plitidepsin + dexamethasone
  • Active Comparator: Arm B
    dexamethasone single agent
    Intervention: Drug: dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: José Rodríguez Diaz-Pavón, M.D. +34 91-846-6157 ext -- jrodriguez@pharmamar.com
United States,   Australia,   Austria,   Belgium,   Czech Republic,   France,   Germany,   Greece,   Ireland,   Italy,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Spain,   Taiwan,   United Kingdom
 
NCT01102426
APL-C-001-09
Yes
PharmaMar
PharmaMar
Not Provided
Principal Investigator: Óscar F. Ballester, M.D. Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Principal Investigator: Rubén Niesvizky, M.D. NY Presbyterian Hosp. - Cornell University - NY
PharmaMar
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP