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Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

2014-07-24 14:33:49 | BioPortfolio

Summary

Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

Thalidomide and Dexamethasone, Dexamethasone

Location

Clinical Research Consultants, Inc.
Hoover
Alabama
United States
35216

Status

Active, not recruiting

Source

Celgene Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:33:49-0400

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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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