Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide
The main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.
There are two parts to this study:
- The first part of this study (Phase 1) will determine a safe dose of the medication cyclophosphamide in combination with pomalidomide and dexamethasone.
- Once the safest dose has been determined, this study (Phase 2) will look to see the difference in effectiveness of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide for the treatment of patients who have myeloma, which has relapsed to or become refractory (not responding) to prior treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pomalidomide, Dexamethasone, Cyclophosphamide
University of California San Francisco
H. Lee Moffitt Cancer Center and Research Institute
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01432600
- Information obtained from ClinicalTrials.gov on February 27, 2013
Medical and Biotech [MESH] Definitions
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
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.
An anti-inflammatory 9-fluoro-glucocorticoid.
A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.
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