EUCTR2010-019462-92-FR进行中（未招募）不适用
Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma. - CARMYSAP
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.
- •1.Must understand and voluntarily sign an informed consent form
- •2.Age > 65 years at the time of signing consent
- •3.Previously untreated, symptomatic multiple myeloma as defined by the 2 criteria below:
- •MM diagnostic criteria (all 3 required):
- •oMonoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy-proven plasmacytoma
- •oMonoclonal protein present in the serum and/or urine
- •oMyeloma-related organ dysfunction (at least one of the following)
- •[C] Calcium elevation in the blood (serum calcium >10.5 mg/L or upper limit of normal)
- •[R] Renal insufficiency (serum creatinine >2 mg/dL)
- •[A] Anemia (hemoglobin <10 g/dL or 2 g < normal)
- •[B] Lytic bone lesions or osteoporosis
- •AND have measurable disease by protein electrophoresis analyses as defined by the following:
- •IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ? 0.5 g/dL or urine M-protein level 200 mg/24 hours
- •IgA multiple myeloma: Serum M-protein level ? 0.5 mg/dL or urine M-protein level 200 mg/24 hours
- •IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
- •IgD multiple myeloma: Serum M-protein level ? 0.05 g/dL or urine M-protein level 200 mg/24 hours
- •Light chain multiple myeloma: Patients with serum free light chain disease in whom the involved light chain measures = 10 mg/dL
- •4.ECOG performance status of 0, 1, or 2
- •5.Able to adhere to the study visit schedule and other protocol requirements
- •6.Life-expectancy > 3 months
- •7.Affiliation number to National Health Care System
- •8.Karnofsky performance status (KPS) of at least 60%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following exclusion criteria are not eligible to enroll in this study.
- •1.Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of consent
- •2.Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study.
- •3.Any of the following laboratory abnormalities
- •Absolute neutrophil count (ANC) < 1,000 cells/?L (1.0 x 109/L)
- •Platelet count < 50,000 cells/?L (50 × 109/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count < 30,000/?L for patients in whom ? 50% of bone marrow nucleated cells are plasma cells
- •Serum SGPT/ALT > 3.0× upper limit of normal (ULN); Bilirubin >2× ULN [ALT more specific to liver]
- •Creatinine clearance = 30 mL/min (Cockcroft-Gault calculation)
- •4.Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ? 3 years. Exceptions include the following:
- •Basal cell carcinoma of the skin
- •Squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- •5.Peripheral neuropathy of > grade 2 severity.
- •6.Myocardial infarction within 3 months of enrollment, unstable angina within 2 months or New York Heart Association class III or IV heart failure.
- •7.Known HIV positivity or active infectious hepatitis, type A, B, or C.
- •8.Female of childbearing potential
- •9.Oral or IV fluid hydration contraindicated
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