EUCTR2008-003829-16-DE进行中（未招募）1 期
An open, randomized clinical phase I/II trial to investigate maximum tolerated dose, efficacy, and safety of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide compared to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses IV in patients with relapsed/refractory multiple myeloma - MM_LEN_DEX_CY
GMIHO - Gesellschaft für medizinische Innovation Hämatologie und Onkologie mbH0 个研究点目标入组 70 人开始时间: 2009年5月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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 = 18 years at the time of signing the informed consent form.
- •3. Able to adhere to the study visit schedule and other protocol requirements.
- •4. Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st – 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
- •5. At least one measurable disease manifestation defined as follows:
- •For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of = 200 mg/24 h.
- •For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
- •6. ECOG performance status of <= 2 at time of randomization/registration
- •7. Laboratory test results within these ranges within 1 week prior to randomization/registration:
- •Absolute neutrophil count = 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
- •Platelet count = 75 x 109/L without transfusion support within 14 days before the laboratory test.
- •Hemoglobin = 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
- •Calculated creatinine clearance = 50 mL/minute.
- •Total bilirubin <= 1.5 mg/dL.
- •AST (SGOT) and ALT (SGPT) <= 2,5 x ULN.
- •Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L).
- •8. Contraception for females of childbearing potential and male subjects (For details see protocol)
- •9. Disease free of prior malignancies for = 5 years with exception of treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
- •10. Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
- •11. Life-expectancy > 3 months.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- •3. 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.
- •4. Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration.
- •5. Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide.
- •6. Any prior use of lenalidomide.
- •7. Concurrent use of other anti-cancer agents or treatments.
- •8. Known positive for HIV or currently active hepatitis, type A, B or C.
- •9. Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
- •10. Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
- •11. Major surgery within 4 weeks before randomization/registration.
- •12. Myocardial infarction within 6 months before randomization/registration, New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •13. Cardiac amyloidosis.
- •14. 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.
- •15. Any systemic infection requiring treatment.
- •16. Cystitis.
- •17. Disturbance of urinary flow.
- •18. Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
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