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Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

2014-07-23 21:12:17 | BioPortfolio

Summary

This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when added to the combination of bortezomib and dexamethasone in multiple myeloma patients who have relapsed on a prior bortezomib treatment regimen.

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

Perifosine, Perifosine Placebo, Bortezomib, Dexamethasone

Location

Keryx / AOI Pharmaceuticals Investigative Site
LaVerne
California
United States
91750

Status

Recruiting

Source

Keryx / AOI Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:17-0400

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Phase I/II Study of Safety & Efficacy of Perifosine & Bortezomib With or Without Dexamethasone for Multiple Myeloma Patients

This is a phase I/II study of perifosine in combination with bortezomib—with or without dexamethasone—for patients with relapsed or refractory multiple myeloma previously treated with ...

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PubMed Articles [6847 Associated PubMed Articles listed on BioPortfolio]

Systems Modeling of Bortezomib and Dexamethasone Combinatorial Effects on Bone Homeostasis in Multiple Myeloma Patients.

Osteolytic bone disease is one of the most debilitating manifestations of multiple myeloma (MM). Bortezomib is a proteasome inhibitor that shows both anticancer and bone anabolic properties and is bei...

Cost-effectiveness of lenalidomide in combination with dexamethasone compared to bortezomib in combination with dexamethasone for the second-line treatment of multiple myeloma in Chile.

Multiple myeloma is a hematologic malignancy affecting bone marrow derived plasma cells. Current therapies are not able to eradicate the disease and most patients become refractory to the treatment. L...

Elucidating the beneficial effects of melphalan, adriamycin, and corticoids in combination with bortezomib against multiple myeloma in vitro.

Combining bortezomib with other anti-cancer drugs or glucocorticoids is more efficient in multiple myeloma than bortezomib alone. However, the molecular mechanism of this beneficial effect is largely ...

Clinical outcomes of bortezomib-based therapy in myeloma.

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Proteasome inhibitor-based therapy for treatment of newly diagnosed multiple myeloma.

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Medical and Biotech [MESH] Definitions

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

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.

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.

An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.

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