Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
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
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01002248
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:12:17-0400
Clinical Trials
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 ...
This is an open label trial for patients currently enrolled in other perifosine trials.
Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The current protocol will enroll patie...
Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
The purpose of this research study is to assess the response rate of perifosine in patients with relapsed or refractory Waldenstrom's macroglobulinemia. Perifosine is a newly discovered c...
Phase I Trial of Paclitaxel With Perifosine
This is a study of the drug perifosine given in combination with paclitaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Paclitaxel is a standard ...
PubMed Articles
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...
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...
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.
Bortezomib, a first generation proteasome inhibitor, is used in both newly diagnosed and relapsed myeloma settings. Considerable differences exist in the usage of bortezomib therapy in the clinical pr...
Proteasome inhibitor-based therapy for treatment of newly diagnosed multiple myeloma.
Multiple myeloma is a hematologic malignancy that is unable to be cured and has significant impact throughout the world. Front line treatment has shifted but ultimately has landed on a bortezomib-base...
Medical and Biotech [MESH] Definitions
Bortezomib
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.
Smoldering Multiple Myeloma
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.
Leukemia, Plasma Cell
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.
Myeloma Proteins
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Bence Jones Protein
An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.
