EUCTR2011-004651-40-AT进行中（未招募）不适用
A multi-center, open label, uncontrolled, Phase IIa clinical trial evaluating the safety and efficacy of NOX-A12 in combination with a background therapy of bortezomib and dexamethasone (VD) in previously treated patients with multiple myeloma (MM) - NOX-A12 in combination with bortezomib and dexamethasone in Multiple Myeloma.
OXXON Pharma AG0 个研究点目标入组 28 人开始时间: 2012年1月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
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.Male or female, aged = 18 years
- •2.Diagnosis of relapsed multiple myeloma for which bortezomib/dexamethasone would be given as standard of care.
- •3.Bortezomib-naïve or bortezomib-sensitive patient (i.e. best response of PR or better, sustained for at least 6 months), who did not receive bortezomib during the last line of therapy for MM prior to this study.
- •4.Progressive disease according to International Myeloma Working Group criteria.
- •5.Pre-study WHO Performance Status = 2 and modified CIRS score of less than 7
- •6.Signed and dated, written informed consent.
- •7.Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment.
- •8.Acceptable liver function: Bilirubin = 1.5 x upper limit of normal (ULN) (according to the Summary of Product Characteristics of Velcade).
- •9.Acceptable hematology and hemostasis status: Platelet count = 75 x 109/L, ANC > 0.75x109/L.
- •10.Acceptable renal function: Serum creatinine =1.5 ULN and/or calculated creatinine clearance = 50 mL/min (calculated according to Cockroft & Gault formula).
- •11.No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound.
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1.The patient has a history of, or is clinically suspicious for, cancer-related Central Nervous System disease.
- •2.Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for alloSCT as assessed by their treating physician.
- •3.Patient has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
- •4.The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration.
- •5.Female patient is pregnant or breast-feeding.
- •6.Known infection with HIV, active Hepatitis B or Hepatitis C.
- •7.The patient has a history of prior toxicity from bortezomib or dexamethasone that resulted in permanent discontinuation of respective treatments.
- •8.Clinical evidence of a current significant (grade 2 or higher) or progressive neuropathy.
- •9.Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration.
- •10.Uncontrolled hypertension (defined as systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg).
- •11.Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration.
- •12.Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation).
- •13.Systemic illnesses or other severe concurrent disease or alcoholism, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments.
- •14.Known or suspected of not being able to comply with the trial protocol.
- •15.Having been previously enrolled in this clinical trial.
研究者
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