Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
研究概览
简要总结
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
详细描述
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..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Revlimid, Cyclophosphamide, Prednisone
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.
干预措施: lenalidomide (Revlimid®) (Drug)
Revlimid, Cyclophosphamide, Prednisone
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.
干预措施: Cyclophosphamide (Drug)
Revlimid, Cyclophosphamide, Prednisone
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.
干预措施: Prednisone (Drug)
结局指标
主要结局
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
时间窗: After 6 cycles
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.
次要结局
- Quality of Life Using the FACT-G Data(baseline and after last cycle (up to 6 cycles))
- Treatment Related Adverse Events Grade 3 or Higher(Beginning of treatment up to 5 years)
研究者
Attaya Suvannasankha
Assistant Professor of Medicine
Indiana University School of Medicine