EUCTR2011-004651-40-IT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3月8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
- 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, sus-tained for at least 6 months), who did not receive
- •XML File Identifier: tFf/2U23CKLpAYA5nzg9lWnLEck=
- •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),
- •AST (SGOT) and ALT (SGPT) = 2.5 ULN at screening.
- •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: 0
- •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, cancerrelated 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
- •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.
- •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
- •15.Having been previously enrolled in this clinical trial.
研究者
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