NCT01090089已完成3 期
The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH31 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2010年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 348
- 试验地点
- 31
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign an informed consent form.
- •Age 60-75 years at the time of signing the informed consent form.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Symptomatic MM requiring therapy.
- •Measurable monoclonal protein in serum and/or urine
- •Monoclonal plasma cells in the bone marrow >/= 10% and/or biopsy-proven plasmacytoma
- •Myeloma-related organ dysfunction, at least one of [C] Calcium elevation in the serum (> 11.5 mg/dL or > 2.65 mmol/l) [R] Renal insufficiency (creatinine > 173 μmol/l or > 2 mg/dL) [A] Anemia (Hb < 10 g/dL or 2 g/dL < normal) [B] Bone lesions or general osteoporosis
- •ECOG PS of </= 2 ...
- •Laboratory test results within these ranges within 1 week prior to randomization:
- •ANC >/= 1.0 x 109/L.
- •Platelet count >/= 75 x 109/L or in case of bone marrow infiltration with myeloma cells >/= 30 x 109/L.
- •Total bilirubin </= 2 mg/dL.
- •AST (SGOT) and ALT (SGPT) </= 3 x ULN.
- •Female subjects of childbearing potential must: o Understand the study drug is expected to have a teratogenic risk
- •o Agree to use, ..., effective contraception without interruption,...
- •o Understand that even if she has amenorrhea, she must follow all the advice on effective contraception.
- •o She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
- •o Agree to have a medically supervised pregnancy test ...
- •Male subjects must
- •o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy ...
- •Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •All subjects must
- •Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- •Agree not to share study drug with another person and to return all unused study drug to the investigator.
- •Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- •Able to receive antithrombotic prophylaxis (...).
- •Life-expectancy > 3 months.
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
- •Pregnant or lactating females
- •Any condition, incl. the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Patient currently is enrolled in another clinical research study or has been enrolled ...within 4 weeks before randomization and/or is receiving an investigational agent for any reason ...
- •Known hypersensitivity to thalidomide, dexamethasone, or melphalan.
- •The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •Any prior use of lenalidomide.
- •Concurrent use of other anti-cancer agents or treatments.
- •Known positive for HIV or active infectious hepatitis, type A, B or C or treponema pallidum
- •Prior treatment with dexamethasone discontinued because of ≥ grade 3 dexamethasone-related toxicity.
- •Any prior chemotherapy with the exception of a short course of dexamethasone more than 4 weeks before randomization.
- •Immunotherapy or antibody therapy within 8 weeks before randomization.
- •Major surgery within 4 weeks before randomization.
- •Renal failure requiring dialysis.
- •Myocardial infarction within 6 months before randomization, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •Severe pulmonary disease (diffusion capacity < 60% of normal).
- •Treatment for cancer other than MM within 5 years before randomization, with the exception of basal cell carcinoma or cervical cancer in situ.
- •Cardiac amyloidosis.
- •Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
- •Any systemic infection requiring treatment.
- •Unability or unwillingness of the patient to receive antithrombotic prophylaxis.
研究组 & 干预措施
Lenalidomid, PBSCT
Experimental
A1 Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)
干预措施: Lenalidomide, Dexamethasone, PBSCT (Drug)
Lenalidomid
Active Comparator
A2 Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years
干预措施: Lenalidomide, Dexamethasone (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 5 yrs
To compare the efficacy of both treatment regimens with regard to progression-free survival.
次要结局
- Overall survival (OS)(5 yrs)
- • Response (complete response [CR], stringent complete response [sCR], very good partial response [VGPR], partial response [PR] and overall response [CR (incl. sCR)+ VGPR + PR]) according to IMWG criteria(5 yrs)
研究者
研究点 (31)
Loading locations...
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