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Aplidin - Dexamethasone in Relapsed/Refractory Myeloma (ADMYRE)

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ClinicalTrials.gov Identifier: NCT01102426
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Tracking Information
First Submitted Date  ICMJE March 31, 2010
First Posted Date  ICMJE April 13, 2010
Last Update Posted Date January 4, 2018
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
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 ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01102426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
  • 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 ]
    Overal Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Official Title  ICMJE Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
Brief Summary Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
Detailed 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).
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Multiple Myeloma
Intervention  ICMJE
  • 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.
Study Arms
  • Experimental: Arm A
    plitidepsin + dexamethasone combination
    Intervention: Drug: plitidepsin + dexamethasone
  • Active Comparator: Arm B
    dexamethasone single agent
    Intervention: Drug: dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 12, 2010)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Czechia,   France,   Germany,   Greece,   Ireland,   Italy,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01102426
Other Study ID Numbers  ICMJE APL-C-001-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PharmaMar
Study Sponsor  ICMJE PharmaMar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account PharmaMar
Verification Date January 2017

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