An Open-Label Phase II Study of the Safety and Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Response rate (the combined CR + PR + MR) with treatment perifosine
研究概览
简要总结
This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.
详细描述
Treatment: Patients will take three 50 mg tablets of perifosine qhs daily with food. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. Patients who experience toxicity may continue on treatment with doses delayed or reduced.
Evaluations: Serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals.
This study will enroll a total of up to 64 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Major criteria:
- •Plasmacytomas on tissue biopsy.
- •Bone marrow plasmacytosis (> 30% plasma cells).
- •Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) > 3.5 g/dL or immunoglobulin A (IgA) > 2.0 g/dL; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
- •Minor criteria:
- •Bone marrow plasmacytosis (10 to 30% plasma cells)
- •Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- •Lytic bone lesions
- •Normal immunoglobulin M (IgM) < 50 mg/dL, IgA < 100 mg/dL or IgG < 600 mg/dL.
- •Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
- •Any two of the major criteria.
- •Major criterion 1 plus minor criterion b, c or d.
- •Major criterion 3 plus minor criterion a or c.
- •Minor criteria a, b and c or a, b and d.
排除标准
- •Renal insufficiency (serum creatinine levels > 3 mg/dL).
- •Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- •Concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to Day
- •Nitrosoureas must be discontinued 6 weeks prior to Day
- •Subjects with a hemoglobin < 8.0 g/dL.
- •Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- •Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
- •Plasma cell leukemia.
研究组 & 干预措施
Perifosine daily
Patients will take three 50 mg tablets of perifosine daily at bedtime with food. Patients will be examined every three weeks. If patients have no progression it is allowed to receive 8 cycles of perifosine
干预措施: perifosine (Drug)
Perifosine daily + Dexa twice per week
Patients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime.
干预措施: perifosine (Drug)
Perifosine daily + Dexa twice per week
Patients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime.
干预措施: dexamethasone (Drug)
结局指标
主要结局
Response rate (the combined CR + PR + MR) with treatment perifosine
时间窗: Every 3 weeks
To determine the response rate (the combined Complete Response (CR) + Partial Response (PR) + Minor Response (MR) following treatment with perifosine in patients with multiple myeloma who have relapsed following Initial front-line therapy and are refractory to their most recent therapy.
次要结局
- Response rate (CR + PR + MR) with combination therapy(Every 3 weeks)
- Assess the safety and tolerability of perifosine alone and in combination(Every 3 weeks)
- Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination(Every 3 weeks)