EUCTR2012-004315-31-IT进行中（未招募）1 期
An Open-Label Phase I/IIa Study of the Safety and Efficacy of Melphalan-flufenamide (Melflufen) and Dexamethasone Combination for Patients with Relapsed and/or Relapsed-Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
入选标准
- •Eligible patients will be considered for inclusion in this study if they meet all of the following criteria:
- •1. Male or female, age 18 years or older.
- •2. Patient has a diagnosis of multiple myeloma with documented relapsed and/or relapsed-refractory disease.
- •3. Patient has measurable disease defined as any of the following:
- •Serum monoclonal protein = 0.5 g/dL by protein electrophoresis.
- •=200 mg of monoclonal protein in the urine on 24-hour electrophoresis
- •Serum immunoglobulin free light chain =10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio.
- •If no monoclonal protein is detected (non-secretory disease), then = 30% monoclonal bone marrow plasma cells.
- •4. Patient has had at least 2 or more prior lines of therapy. (see appendix D for the definition of lines of therapy);
- •5. Life expectancy of =6 months;
- •6. Patient has an ECOG performance status = 2. (Patients with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible);
- •7. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test prior to starting therapy;
- •8. Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control;
- •9. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information;
- •10.The patient has or, accepts to have, an acceptable infusion device for infusion of melflufen (see Study Reference Manual for acceptable devices);
- •11. 12 lead ECG with QTcF interval of =470 msec;
- •12. The following laboratory results must be met within 21 days, or as specified in the table of assessments, of patient registration:
- •Absolute neutrophil count (ANC) = 1,000 cells/mm3 (1.0 x 109/L) (Growth factors cannot be used within 14 days before patient registration).
- •Platelet count = 75,000 cells/ mm3 (75 x 109/L) (platelet count = 50,000 cells/ mm3 for patients in whom = 50% of bone marrow nucleated cells are plasma cells (without transfusion during the previous 14 days to patient registration).
- •Hemoglobin = 8.0 g/dL (RBC transfusions are permitted)
- •Total Bilirubin = 1.5 X upper limit of normal (ULN);
- •Renal function: Estimated creatinine clearance = 45 ml/min and/or serum creatinine = 2.0 mg/dL;
- •AST (SGOT) and ALT (SGPT) = 3.0 x ULN.
- •† (FCBP) is any sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (not having menstrual cycles due to cancer therapy does not rule out childbearing potential) for at least 24 consecutive 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients will be ineligible for this study if they meet any one of the following criteria:
- •1. Patient has evidence of mucosal or internal bleeding and/or platelet transfusion refractory (i.e., unable to maintain a platelet count =50,000 cells/mm3);
- •2. Any medical conditions that, in the Investigator’s opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, = grade 3 thromboembolic event in the last 6 months), renal insufficiency (unless felt to be secondary to MM);
- •3. Known active infection requiring parenteral or oral anti-infective treatment;
- •4. Other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix;
- •5. Other ongoing anti-myeloma therapy. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg PO q.d. or its equivalent) for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least 7 days prior to study treatment;
- •6. Pregnant or breast-feeding females;
- •7. Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation;
- •8. Known HIV or hepatitis B or C viral infection;
- •9. Patient has concurrent symptomatic amyloidosis or plasma cell leukemia;
- •10. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes);
- •11. Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to patient registration. Biologic, novel therapy (including investigational agents in this class) or corticosteroids within 2 weeks prior to start of patient registration. Patient has side effects of the previous therapy > grade 1 or previous baseline.
- •12. Prior peripheral stem cell transplant within 12 weeks of patient registration;
- •13. Radiotherapy within 21 days prior to patient registration. However, if the radiation portal covered = 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy;
- •14. Known intolerance to steroid therapy.
研究者
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