Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.
详细描述
- Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
- Certain tests and procedures were performed throughout each treatment cycle at definitive time periods. These tests included: medical history update, physical/neurological examination, skeletal survey (x-rays or scan), blood samples, urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT (if needed).
- It was expected that participants were going to complete at least 8 cycles of the study, which adds up to 168 days. If the participant completed the first 8 cycles, had stable or responding disease and had not experienced bad side effects, they were allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.
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
- •Diagnosis of multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
- •Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior regimens
- •Negative serum or urine pregnancy test
- •Age 18 years or older
- •Karnofsky performance status of 60 or greater
排除标准
- •Grade 2 or greater peripheral neuropathy within 14 days before enrollment
- •Renal insufficiency (serum creatinine > 2.5 mg/dL)
- •Evidence of mucosal or internal bleeding and/or platelet refractory
- •ANC < 1000 cells/mm3
- •Hemoglobin < 8.0 g/dL
- •AST or ALT greater than or equal to 2 x ULN
- •Concomitant therapy medications that include corticosteroids
- •Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Clinically relevant active infection or serious co-morbid medical conditions
- •Prior malignancy (within last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer
- •Pregnant or breast-feeding
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Uncontrolled diabetes mellitus
- •Hypersensitivity to acyclovir or similar anti-viral drug
- •POEMS syndrome
- •Known HIV infection
- •Known active hepatitis B or C viral infection
- •Known intolerance to steroid therapy
- •Subjects with primary refractory disease, defined as progression during initial treatment
研究组 & 干预措施
lenalidomide, dexamethasone, bortezomib combination
Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
干预措施: Bortezomib (Drug)
lenalidomide, dexamethasone, bortezomib combination
Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
干预措施: Lenalidomide (Drug)
lenalidomide, dexamethasone, bortezomib combination
Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months
时间窗: 6 months after therapy
Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: \>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) \>25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) \>25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture). Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
次要结局
- Progression Free Survival(aassesed at a median follow-up of 44 months)
- Objective Response Rate(Assessed every cycle for up to 8 cycles and best response was reported)
- Overall Survival(assesed at a median follow-up of 44 months)
- Duration of Response(Assessed at a median follow-up of 44 months)
研究者
Paul G. Richardson, MD
Principle Investigator
Dana-Farber Cancer Institute