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

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

Detailed Description
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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..

Official Title
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Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: lenalidomide (Revlimid®)
* Drug: Cyclophosphamide
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revlimid, Cyclophosphamide, Prednisone<br>Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Prednisone every other day orally. | Drug: lenalidomide (Revlimid®)<br>* 25 mg p.o. daily on days 1-21 of each 28 day cycle<br>* Other names: Revlimid®;Drug: Cyclophosphamide<br>* 50 mg p.o. BID daily on days 1-21 of each 28 day cycle<br>Drug: Prednisone<br>* 50 mg p.o. Q.O.D.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria | Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. | After 6 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Related Adverse Events Grade 3 or Higher | Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater. | Beginning of treatment up to 5 years | 
| Quality of Life Using the FACT-G Data | Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome | baseline and after last cycle (up to 6 cycles) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Revlimid