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Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

2014-07-23 21:09:34 | BioPortfolio

Summary

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

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) and overall survival (OS). The evaluation of efficacy after crossover from dexamethasone alone to plitidepsin and dexamethasone combination, of safety profile on both arms patients and of pharmacokinetics (PK) and pharmacokinetic /pharmacodynamic (PK/PD) relationship will be performed.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Relapsed/Refractory Multiple Myeloma

Intervention

plitidepsin + dexamethasone, dexamethasone

Location

NY Presbyterian Hosp. - Cornell University - NY
New York
New York
United States
10021

Status

Recruiting

Source

PharmaMar

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:34-0400

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Medical and Biotech [MESH] Definitions

An anti-inflammatory 9-fluoro-glucocorticoid.

An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.

An anti-inflammatory, anti-allergic glucocorticoid that can be administered orally, by inhalation, locally, and parenterally. It may cause water and salt retention.

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

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