NL-OMON47533已完成不适用
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 - O-12-M1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 including lenalidomide and bortezomib and has demonstrated disease progression on or within 60 days of completion of the last 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 initiation of 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 (Port A Cath, PICC line or central venous catheter);;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, prior to initiation of therapy:
- •* Absolute neutrophil count (ANC) * 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used within 14 days before initiation of therapy).
- •* Platelet count * 75,000 cells/dL (75 x 109/L) (platelet count * 50,000 cells/dL for patients in whom * 50% of bone marrow nucleated cells are plasma cells (without transfusion during the previous 7 days to initiation of therapy).
- •* 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 or serum creatinine * 2.5 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.
排除标准
- •1. Patient has evidence of mucosal or internal bleeding and/or is 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 initiation of therapy;;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 initiation of therapy. Biologic, novel therapy (including investigational agents in this class) or corticosteroids within 2 weeks prior to initiation of therapy. Patient has side effects of the previous therapy > grade 1 or previous baseline.;12. Prior peripheral stem cell transplant within 12 weeks of initiation of therapy*;;13. Radiotherapy within 21 days prior to initiation of therapy. However, if the radiation portal covered * 5% of the bone marrow reserve, the patient may be enrolled irrespective of he end date of radiotherapy;
- •14. Known intolerance to steroid therapy.
研究者
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