EUCTR2008-003486-58-BE进行中（未招募）1 期
Pharmacogenomic study to predict survival, best response and toxicity in newly diagnosed myeloma patients who are either 65 years of age or older treated with either a combination of melphalan-prednisone-thalidomide or lenalidomide-dexamethasone
Intergroupe Francophone du Myélome0 个研究点目标入组 1,000 人开始时间: 2008年11月18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
- 1,000
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
- •In order to participate in this study protocol, patients must fulfill the following conditions:
- •- Must understand and voluntarily sign and informed consent form
- •- Age = 65 years at the time of signing consent
- •- Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all 3 required):
- •? Monoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy-proven plasmacytoma
- •? Monoclonal protein present in the serum and/or urine
- •? Myeloma-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
- •- Have measurable disease by protein electrophoresis analyses as defined by the following:
- •? IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
- •? IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein level ³ 200 mg/24 hours
- •? IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level = 1.0g/dL or urine M-protein level = 200mg/24hours
- •? IgD multiple myeloma: Serum M-protein level = 0.05 g/dL or urine M-protein level = 200 mg/24 hours
- •? Light chain multiple myeloma: Serum M-protein level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
- •- ECOG performance status of 0, 1, or 2
- •- Treated by either melphalan-prednisone-thalidomide or lenalidomide-dexamethasone
- •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
- •- 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 randomization]
- •- Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study
- •- Any of the following laboratory abnormalities:
- •? Absolute neutrophil count (ANC) < 1,000 cells/µL (1.0 x 109/L)
- •? Platelet count < 50,000 cells/µL (50 x 109/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/µL for patients in whom = 50% of bone marrow nucleated cells are plasma cells
- •? Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •? Creatinine clearance = 30 mL/min (Cockroft-Gault calculation)
- •- 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)
- •- Patients who have are unable or unwilling to undergo antithrombotic therapy
- •- Peripheral neuropathy of > grade 2 severity
- •- Known HIV positivity or active infectious hepatitis, type A, B, or C.
- •- Primary AL amyloidosis and myeloma complicated by amyloidosis.
- •- Renal failure requiring dialysis
研究者
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