Phase III
Study
Type: Interventional
Study
Design: Allocation: Randomized
Endpoint
Classification: Efficacy Study
Intervention
Model: Parallel Assignment
Masking:
Open Label
Primary
Purpose: Treatment
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
Resource
links provided by NLM:
Genetics
Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus
related topics: Cancer Multiple Myeloma
Drug
Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus
Aplidine Dexamethasone Sodium Phosphate
U.S.
FDA Resources
Further
study details as provided by PharmaMar:
Primary
Outcome Measures:
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).
Secondary
Outcome Measures:
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
Estimated Enrollment: 250
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for
primary outcome measure)