Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT00540644

Run by

Attaya Suvannasankha

People needed

70

Starts

2007-10-01

Expected to finish

2014-08-01

Last updated by the study team

2016-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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