Multiple Myeloma Clinical Trial
Official title:
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
Verified date | September 2014 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
Status | Completed |
Enrollment | 70 |
Est. completion date | August 2014 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Cancer Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine | Celgene Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate (RR) after 6 cycles of therapy using the proposed International Myeloma Working Group uniform response criteria | 6 cycles | No | |
Secondary | The biologic effect of the RCP regimen on bone turnover markers. | baseline, 3 months, 6 months | No | |
Secondary | The biologic effect of the RCP regimen on serum cytokine profiling | baseline, 3 months, 6 months | No | |
Secondary | Safety (type, frequency, severity, and relationship of adverse events to study treatment) | assessed every 4 weeks | Yes | |
Secondary | Quality of life using the FACT-G data | baseline, after 3 cycles, after 6 cycles | No |
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