Maintenance Therapy With Lenalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3
研究概览
简要总结
This phase II trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma. Biological therapies, such as lenalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone and clarithromycin may be an effective treatment for multiple myeloma.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the toxicity of the use of lenalidomide/biaxin (clarithromycin)/dexamethasone as maintenance therapy after autologous/syngeneic transplant.
II. Evaluate the median time to disease progression. III. Evaluate survival.
OUTLINE:
Patients receive clarithromycin orally (PO) twice daily (BID) and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily (QD) on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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
- •Any autologous or syngeneic patient who underwent high dose melphalan (>= 140 mg/m^2) therapy/peripheral blood stem cell (PBSC) or bone marrow (BM) rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial which is also evaluating long-term disease free survival or survival
- •Platelet count (transfusion independent) > 50,000 cells/mm^3 and absolute granulocyte count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose therapy
- •Patients should be between 30 days to 120 days after transplant
- •Willingness and ability to comply with Food and Drug Administration (FDA)-mandated REV ASSIST Program, Celgene System for Lenalidomide Education and Prescribing Safety
- •Signing a written informed consent form
排除标准
- •Karnofsky score less than 70
- •A left ventricular ejection fraction less than 45% immediately pre transplant; patients with congestive heart disease with transplant, history of myocardial infarction (MI), or history of coronary artery disease
- •Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease), serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 2.5 x upper limit of normal
- •Calculated by Cockcroft-Gault formula or measured serum creatinine clearance < 25 ml/minute
- •Pregnant and/or lactating females
- •Patients who cannot give informed consent
- •Patients with untreated systemic infection
- •Patients with history prior to transplant of treatment with combination therapy Lenalidomide/Biaxin and steroid without response
- •Patients allergic to lenalidomide, biaxin or dexamethasone
- •Referring physician not registered with REV ASSIST program or unwilling to oversee the care of the patients on study and comply with the FDA-mandated REV ASSIST Program
- •Patients unwilling to practice adequate forms of contraception if clinically indicated until 30 days after stopping therapy; male patients on study need to be consulted to use latex condoms (even if they have had a vasectomy) every time they have sex with a woman who is able to have children while they are being treated and for 30 days after stopping drugs
- •Patients with >= grade 3 peripheral neuropathy
- •Prior history of uncontrollable side effects to dexamethasone therapy
- •A prior history of human immunodeficiency virus (HIV) positivity with pre-transplant evaluation
研究组 & 干预措施
Treatment (clarithromycin, dexamethasone, lenalidomide)
Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.
NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.
干预措施: Clarithromycin (Drug)
Treatment (clarithromycin, dexamethasone, lenalidomide)
Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.
NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.
干预措施: Dexamethasone (Drug)
Treatment (clarithromycin, dexamethasone, lenalidomide)
Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.
NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3
时间窗: First year of therapy
Time to Disease Progression
时间窗: Up to 10.25 years
International Myeloma Working Group Uniform Response Criteria was used
次要结局
- Survival(From date of transplant until the date of death from any cause, assessed up to 10.25 years)
研究者
Leona Holmberg
Principal Investigator
Fred Hutchinson Cancer Center