A Phase II Study of Dexamethasone (DECADRON®), Thalidomide (THALOMID®), and Lenalidomide (REVLIMID®) for Subjects With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Effect of Drug Combination on Multiple Myeloma
研究概览
简要总结
Study Objectives
- To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide and thalidomide when used as monotherapies.
- To evaluate the safety of the combination of lenalidomide, dexamethasone, and thalidomide as a therapy for patients with relapsed or refractory multiple myeloma.
详细描述
This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with both thalidomide and lenalidomide in separate regimens each used as a single agent or in combination with corticosteroids. Up to 45 patients will be enrolled. Patients who sign informed consent form and RevAssist® and S.T.E.P.S® patient agreement form and fulfill all eligibility criteria will be enrolled.
DexTR therapy:
Cycles 1-4
- Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
- Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle.
- Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.
- Prophylactic medications, such as medications for thrombosis risk, will be given.
After completing 4 cycles:
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
- •Subject must voluntarily sign and understand written informed consent.
- •Age > 18 years at the time of signing the consent form.
- •Histologically confirmed Salmon-Durie stage II or III MM. Stage I MM patients will be eligible if they display poor prognostic factors (ß2M ≥5.5 mg/L, plasma cell proliferation index ≥5%, albumin of less then 3.0, and unfavorable cytogenetics).
- •Relapsed or refractory myeloma as defined by Appendix II, table 1, progression of disease either after prior therapy or lack of response to currently used therapy.
- •Prior treatment with prior lenalidomide and thalidomide as single agents or in combination with dexamethasone, but not in combination with each other.
- •No anti-myeloma therapy within 14 days prior to initiation of study treatment. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
- •Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- •Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma.
- •All study participants must be registered into the mandatory RevAssist® and S.T.E.P.S.® programs, and be willing and able to comply with the requirements of the RevAssist® and S.T.E.P.S.® programs.
- •Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and thalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
- •Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- •Life expectancy ≥ 3 months
- •Subjects must meet the following laboratory parameters:
- •Absolute neutrophil count (ANC) ≥1000 cells/mm3 (1.0 x 109/L)
- •Platelets count ≥ 75,000/mm3 (75 x 109/L)
- •Serum SGOT/AST <3.0 x upper limits of normal (ULN)
- •Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
- •Serum creatinine <2.5 mg/dL (221 µmol/L)
- •Serum total bilirubin <2.0 mg/dL (34 µmol/L)
排除标准
- •Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
- •Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years.
- •Myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •Pregnant or lactating females are ineligible.
- •Given the potential of the study drugs to trigger or worsen HIV viremia and the incidence of opportunistic infections inpatients infected with the HIV virus, HIV-1 or HIV-2 positive patients will be excluded. The interactions of HAART with study drugs have not been determined.
- •Active hepatitis B or hepatitis C infection.
- •Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- •Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
- •Known hypersensitivity to dexamethasone, lenalidomide, or thalidomide.
- •History of thromboembolic event within the past 6 months prior to enrollment.
研究组 & 干预措施
DexTR (all patients)
All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.
干预措施: dexamethasone (Drug)
DexTR (all patients)
All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.
干预措施: thalidomide (Drug)
DexTR (all patients)
All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.
干预措施: lenalidomide (Drug)
结局指标
主要结局
Effect of Drug Combination on Multiple Myeloma
时间窗: The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks
The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
次要结局
未报告次要终点