Phase I Dose Escalation Trial of High Dose Melphalan Conditioning Regimen With Palifermin for Cytoprotection Followed by Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of melphalan when treated with palifermin to prevent mucositis
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for multiple myeloma.
PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with palifermin in treating patients undergoing an autologous peripheral stem cell transplant for stage II or stage III multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of high-dose melphalan when administered with palifermin in patients undergoing autologous peripheral blood stem cell transplantation for stage II or III multiple myeloma.
Secondary
- Assess overall response (complete and partial response and stable disease) in these patients at 28 and 100 days post-transplantation.
- Assess the efficacy of palifermin as a cytoprotective agent in reducing incidence and duration of mucositis in patients treated with this regimen.
- Assess patient-reported outcomes and impact of palifermin on quality of life of these patients.
- Assess the qualitative and quantitative toxicities of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Palifermin & Melphalen
Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:
Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;
Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:
Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
干预措施: Palifermin (Biological)
Palifermin & Melphalen
Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:
Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;
Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:
Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
干预措施: melphalan (Drug)
Palifermin & Melphalen
Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:
Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;
Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:
Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
干预措施: questionnaire administration (Other)
Palifermin & Melphalen
Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:
Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;
Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:
Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
干预措施: autologous peripheral blood stem cell transplantation (Procedure)
Palifermin & Melphalen
Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:
Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;
Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:
Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
干预措施: quality-of-life assessment (Other)
结局指标
主要结局
Maximum tolerated dose of melphalan when treated with palifermin to prevent mucositis
时间窗: Days -5, -4, -3, 2, +1, +2 and +3
次要结局
- Dose-limiting toxicity(Days -5, -4, -3, 2, +1, +2 and +3)
- Evaluate the efficacy of Palifermin as a cytoprotective agent in reducing incidence and duration of Grade 3 and 4 mucositis due to high dose Melphlan(Day -5 to Day +28)
- Overall response(At Day 28 and Day100 after autologous transplant when treated with combination of palifermin and Melphalan)
- Reduction in incidence and duration of mucositis(Days -5 to Day +28)
研究者
Muneer Abidi
Principal Investigator
Barbara Ann Karmanos Cancer Institute