EUCTR2005-006024-11-DE进行中（未招募）不适用
Prospective, open label, multi center phase II clinical trial of oral BAY 43-9006 (Sorafenib) in patients with relapsed or refractory multiple myeloma - not applicable
niversity hospital of Bonn0 个研究点开始时间: 2006年7月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-informed consent
- •-histologically or cytologically confirmed Multiple Myeloma in Stage IIA or IIIA (Durie and Salmon).
- •-Measurable disease, definerd by:
- •-Serum M protein at least 1.0 g/dl by protein electrophoreses or free light chain measurement an/or –
- •-quantitative immunoglobulins and/or urinary M protein excretion of at least 200 mg/24 hours.
- •-Relapse following any conventional multiple myeloma therapy (including autologous stem cell transplantation), or refractory to their most recent multiple myeloma therapy (including immunotherapy, radiation therapy, or other investigational agents). Note: Patients need not to have responded to the previous (one) therapeutic regimen.
- •-Male or female patients > 18 years of age.
- •-Life expectancy of at least 12 weeks
- •-Patients must have an ECOG performance status of less or equal 2
- •-Women of childbearing age with a negative pregnancy test within 7 days prior to enrolment and willing to use adequate contraception during therapy
- •-Men and women: Willing to use adequate contraceptive barrier methods during treatment.
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with non-secretory myeloma and plasma cell leukemia
- •-Patients eligible and willing to undergo second-line high-dose therapy or ABSCT.
- •-Hypercalcaemia >3.0 mmol/l (14 mg/dl)
- •-Insufficient bone marrow, liver, and renal function as assessed by the following laboratory investigations at screening (Note: Values obtained within 7 days prior to the screening visit can be used): (Hemoglobin < 9.0 g/l, Absolute neutrophil count < 1.500/mm³, Platelets < 50.000/mm³, Total bilirubin > 1.5 x upper limit normal, ALT and AST > 2.5 x upper limit normal, Amylase and lipase > 1.5 x upper limit normal, Serum creatininie > 2.0 x upper limit normal, PT or INR and PTT > 1.5 x upper limit normal)
- •-Major surgery within 4 weeks of enrolment
- •-Patients with history of other malignancies during the past 5 years with the exception of adequately treated basal or squamous-cell skin cancer or cervical carcinoma or localized prostate carcinoma.
- •-Systemic amyloidosis (except amyloidosis of skin or bone marrow).
- •-Known history of HIV infection or chronic hepatitis B or C infection.
- •-Active clinically serious bacterial or fungal infections (>or equal grade 2 NCI-CTCAE, Version 3.0).
- •-Manifest depression
- •-History of cardiac disease: congestive heart failure >NYHA class 2, active cardiovascular disease (MI more than 6 months prior to study entry is allowed); cardiac arrhythmia requiring antiarrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- •-Known neoplastic CNS abnormality
- •-Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- •-Patients with seizure disorder requiring medication.
- •-Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study.
- •-Pregnant or breast feeding patients.
- •-Concurrent anticancer chemotherapy or immunotherapy. (Note: The administration of bisphosphonates is recommended and not excluded).
- •-Concurrent treatment with systemic corticosteroids.
- •-Prior use of inhibitors of the Ras/Raf-, MEK-, AKT-kinase- and mTOR-signaling pathway or of farnesyl-transferase inhibitors.
- •-Prior use of angiogenesis inhibitors (targeting VEGF/VEGFR, PDGF/PDGFR and other key molecules in angiogenesis). Note: the prior use of thalidmide and its derivatives is no exclusion criterium.
- •-Concomitant Rifampicin and St. John´s Wort (hypericum perforatum).
- •-Receiving immunotherapy, radiation therapy, or other investigational agents within 30 days prior to the first study drug administration.
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