EUCTR2016-000287-42-FR进行中（未招募）1 期
A Multicentre Open label Phase II study of Daratumumab in AL AmyloidosisPatients not in VGPR or Better - AMYDARA
CHU de Limoges0 个研究点目标入组 40 人开始时间: 2016年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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.Histologic diagnosis of AL amyloidosis
- •2.Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis or immunohistochemistry of amyloid deposits must provide clear evidence of kappa or lambda light chains in those who present with peripheral neuropathy or heart as the dominant organ involvement.
- •3.Patients must be >=18 years of age
- •4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •5.Patients should have received at least one line with an alkylating agent and/or a proteasome inhibitor and dexamethasone and not be in VGPR or CR at the time of inclusion (patients who did not reach VGPR or patients who reached VGPR or better but have an hematological relapse can be included).
- •6.Measurable hematologic disease: difference between involved and uninvolved FLC > 50 mg/L with an abnormal kappa/lambda ratio (with Freelite® test kits, The Binding Site)
- •7.Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system)
- •8.Wash out period of at least 4 weeks from previous antitumor therapy or any investigational treatment or 5 half-lives from previous antibodies, whichever is longer,
- •9.Adequate bone marrow function prior to 1st drug intake (C1D1), without transfusion or growth factor support within 5 days prior to 1st drug intake,
- •10.Adequate organ function defined as:
- •-Serum creatinine clearance (Cockcroft-Gault formula) >= 30 ml/min
- •-Serum SGOT/AST or SGPT/ALT < 3.0 X Upper Limit Of The Normal Range (ULN)
- •-Serum total bilirubin < 2.0 mg/dL, unless the patient has Gilbert’s syndrome where the direct bilirubin should then be < 2.0 mg/dL
- •11.Women who are partners of men and with childbearing potential*(defined below) must be practicing a methods of birth control
- •12.A woman with childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 14 days prior to dosing and the second within 48 hours prior to dosing, and remain on a highly effective method of birth control. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. FCBP must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception,
- •Highly effective methods :
- •Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation, Partner’s vasectomy
- •Additional effective methods :
- •Male condom, Diaphragm, Cervical Cap
- •Serum (urine in the case where serum is not possible in a timely manner) pregnancy test to be performed for all women of childbearing potential regularly during the therapy. In addition, a pregnancy test may be done at any time during the study at the discretion of the investigator if a subject misses a period or has unusual menstrual bleeding
- •13.A woman of childbearing potential must remain on a highly effective method of birth control. Contraception must begin 4 weeks before initiating treatment with Daratumumab, during therapy, during dose interruptions and continuing for 3 months following discontinuation of Daratumumab. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy
- •14.A man who has not had a vasectomy and who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control e.g., condom with spermicidal foam/gel/
排除标准
- •1. Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis
- •2.Isolated soft tissue involvement
- •3.Presence of non-AL amyloidosis
- •4.Bone marrow plasma cells >30% on bone marrow aspirate at screening
- •5.Cardiac mayo stage IIIb disease. (i.e. cardio mayo stage III with NT-proBNP >= 8500 ng/L
- •6.Repetitive ventricular arrhythmias on 24h Holter ECG despite anti-arrhythmic treatment, except if a pacemaker has been implanted.
- •7.Chronic atrial fibrillation
- •8.Supine systolic blood pressure <100 mmHg
- •9.Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen. Or, subject is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen
- •10.Clinically overt multiple myeloma with lytic bone lesions
- •11.Patients with uncontrolled infection or active malignancy with the exception of
- •-adequately treated basal cell or squamous cell skin cancer,
- •-in situ cervical cancer
- •-low grade (Gleason 3+3 or less) prostate cancer or in situ breast carcinoma if surgically treated
- •-adequately treated Stage I cancer from which the patient is currently in complete remission,
- •-or any other cancer from which the patient has been disease-free for 3 years.
- •12.Any uncontrolled or severe cardiovascular or pulmonary disease determined by the investigator including:
- •- NYHA functional classification IV congestive heart failure
- •- LVEF (Left Ventricular Ejection Fraction) <45%
- •- Uncontrolled angina, hypertension or arrhythmia
- •- Myocardial infarction in the past 6 months
- •13.Subjects with psychiatric illnesses or social situations that would preclude them understanding the informed consent, study compliance or the ability to tolerate study procedures and/or study therapy
- •14.Subjects with known/underlying medical conditions that, in the investigator’s opinion would make the administration of the study drug hazardous (ie: uncontrolled diabetes or uncontrolled coronary artery disease)
- •15.Subjects with known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal
- •16.Subject has known moderate or severe persistent asthma within the past 2 years (see APPENDIX 8), or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
- •17.Previous anti-CD38 therapy
- •18.Hypersensitivity to Dexamethasone that would prohibit treatment with study therapy
- •19.Known positive for HIV or active hepatitis B or C
- •20.Refusal to consent or protected by legal regime
研究者
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