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
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Multiple Myeloma||Drug: plitidepsin + dexamethasone Drug: dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Arm A
plitidepsin + dexamethasone combination
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)
Active Comparator: Arm B
dexamethasone single agent
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102426
|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|