A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Objective Response Rate
研究概览
简要总结
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.
详细描述
If you are willing to participate in this study you will be asked to undergo some screening procedures and tests to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care. They may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, physical exam, performance status, vital signs, neurological exam, bone imaging studies, chest x-ray, bone marrow aspirate, ECG, blood tests and urine tests. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in the research study.
For cycles 1-9 (each cycle lasts 35 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib- once a day on Days 1, 8, 15 and 22. If you are one of the first ten patients enrolled you will get Bortezomib as an intravenous injection for the first cycle. You will get Bortezomib as an injection under the skin for all other cycles. If you are not one of the first 10 patients enrolled you will get Bortezomib as an injection under the skin for all cycles. Dexamethasone-if you are 75 years old or younger you will get Dexamethasone on Days 1, 2, 8, 9, 15, 16, 22 and 23. If you are more than 75 years old you will get Dexamethasone on Days 1, 8, 15 and 22. You will take Dexamethasone by mouth at the same time each day.
For cycles 10-15 (each cycle lasts 28 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib-Once a day on Days 1 and 15. You will get Bortezomib as an injection under the skin. You will be given a drug diary to record taking your doses of the drugs. The study staff will tell you how to complete the diary.
During the study you will have to come to the clinic for visits. The tests and procedures that will be done at each visit are listed below:
Day 1 of all cycles: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum (cycle 1 only), urine test.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented symptomatic myeloma, with organ damage related to myeloma
- •Myeloma that is measurable either by serum or urine evaluation of the monoclonal component or by assay of serum free light chains
- •Must commit to complete abstinence from heterosexual contact or begin two acceptable method of birth control, one highly effective method and one additional effective (barrier) method
排除标准
- •Eligible for autologous stem cell transplantation
- •HIV positive on combination antiretroviral therapy
- •Pregnant or breastfeeding
- •Treated with any prior systemic therapy
- •Primary amyloidosis or myeloma complicated by amyloidosis
- •Receiving other investigational agents within 14 days of the start of this trial or during this trial
- •Known brain metastases
- •Poor tolerability or known allergy to any of the study drugs or similar compounds
- •Intercurrent illness
- •Previous history of another malignant condition except for basal cell carcinoma or stage I cervical cancer
- •Inability to comply with an anti-thrombotic treatment regimen
- •Peripheral neuropathy greater than or equal to grade 2
研究组 & 干预措施
Treatment Arm
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
干预措施: Lenalidomide (Drug)
Treatment Arm
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
干预措施: Bortezomib (Drug)
Treatment Arm
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 2 years
Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following: * Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) * CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours * PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required
次要结局
- Median Progression Free Survival(From the start of treatment until death or progression or until 3 years after the last participant is enrolled)
- Number of Participants With Grade 3 or Higher Treatment Related Adverse Events(2 years)
- Median Overall Survival(From the start of treatment until death or until 5 years after the time of disease progression)
- Median Time to Response(From the start of treatment until the time of first documented response, median duration of 1.1 months)
- Pharmacogenomic Markers of Neuropathy(2 years)
- Response Rate With Respect to Cytogenetic Characteristics(2 years)
- Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection(Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose)
研究者
Noopur Raje
Principal Investigator
Massachusetts General Hospital