EUCTR2008-006497-15-DE进行中（未招募）1 期
enalidomide and Dexamethasone for treatment of patients with acute myeloma (light chain)-induced renal failure - LD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Understand and voluntarily sign an informed consent form.
- •2. Age at least 18 years at the time of signing the informed consent form.
- •3. MM (all stages) with acute light chain induced renal impairment
- •a) Patients with previously unknown MM and acute light chain induced renal failure (GFR<50ml/min serum creatinine minimum 2.0 mg/dL) and with further workup revealing light chain induced renal injury with MM as underlying cause.
- •b) Patients with previously established MM and normal renal function (GFR at least 60ml/min and serum creatinine =1.2mg/dl) with progressive disease and acute (within 6 weeks) light chain induced renal failure (GFR<50ml/min and creatinine = 2.0 mg/dL).
- •4. All previous medical anti-myeloma therapy (excluding corticosteroids) must have been discontinued at least 3 weeks prior to treatment in this study.
- •5. Able to adhere to the study visit schedule and other protocol requirements.
- •6. Measurable serum or urine paraprotein
- •7. Laboratory test results within these ranges:
- •Glomerular filtration rate < 50ml/min
- •Serum creatinine = 2.0mg/dL
- •Absolute leukocyte count minimum 1.5 x 109/L
- •Platelet count minimum 75 G/L if bone marrow plasma cell infiltration (BMPC) is >50% or at least 30 G/L if BMPC infiltration is <50%.
- •Total bilirubin not more than 1.5 mg/dL
- •AST (SGOT) and ALT (SGPT) not more than 2,5 x ULN
- •8. Females of childbearing potential (FCBP) must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis. If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
- •10. Disease free of prior malignancies for at least 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
- •11. Agree to take low molecular weight heparin as prophylactic anticoagulation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Acute renal failure due to other causes than light-chain induced nephropathy such as NSAIRS, antibiotics, or other nephrotoxic drugs, or others.
- •2. Acute renal failure due to hypercalcemia only, without excretion of nephrotoxic light chains.
- •3. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •4. Any prior use of lenalidomide
- •5. Any anti-myeloma therapy within 3 weeks before day 1 of first cycle, with the exception of dexamethasone 40mg (maximum dose 160mg) or corticosteroid equivalent.
- •6. Any other experimental drug or therapy within 3 weeks of baseline
- •7. Any condition, including 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.
- •8. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •9. Known positive for HIV or infectious hepatitis, type A, B or C or evidence of any severe active or chronic infection.
- •10. Clinical significant heart disease (NYHA status>2)
- •11. Pregnant or breast feeding females
- •12. Anamnesis of thromboembolic complications, such as stroke, myocardial infarction and pulmonary embolism
- •13. Known hypersensitivity to thalidomide and/or lenalidomide
研究者
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