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Indianapolis, Indiana 46202


Purpose:

The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.


Study summary:

This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..


Criteria:

Inclusion Criteria: Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria: - Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma PLUS one or more of the following: - Calcium elevation (11.5 mg/dl) [42.65 mmol/l] - Renal insufficiency (1.5 x the ULN of serum creatinine) - Anemia (hemoglobin <=10 g/dl or 2 g/dl <= normal) - Bone disease (lytic lesions or osteopenia) Measurable disease is defined at least one of the following three measurements: - Serum M-protein >=1 g/dl ( or 10 g/l) - Urine M-protein >=200 mg/24 h - Serum FLC assay: Involved FLC level >=10 mg/dl (>=100 mg/l) provided serum FLC ratio is abnormal - Measurable plasmacytoma - NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response. Laboratory test results within these ranges: - Absolute neutrophil count >= 1.0 x 109/L - Platelet count >= 50 x 10(9)/L - Hemoglobin >= 9 gm/dl - Serum creatinine <= 2.5mg/dL. - Total bilirubin <=1.5 x upper limit of normal - AST (SGOT) and ALT (SGPT) <= 3 x ULN Exclusion Criteria: - Known hypersensitivity to thalidomide - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. - Patients with a solitary plasmacytoma - Patients with uncontrolled diabetes - Patients with ≥ Grade 3 sensory neuropathy - History of cardiac disease, with NYHA Class II or greater


NCT ID:

NCT00540644


Primary Contact:

Principal Investigator
Attaya Suvannasankha, M.D.
Indiana University School of Medicine


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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