EUCTR2012-005683-10-ES进行中（未招募）1 期
Estudio fase III nacional, multicéntrico, abierto, aleatorizado, de tratamiento de inducción con bortezomib/lenalidomida/dexametasona (VRD-GEM), seguido de altas dosis de quimioterapia con melfalán-200 (MEL-200) vs. busulfan-melfalán (BUMEL) y consolidación con VRD-GEM para pacientes con mieloma múltiple sintomático de nuevo diagnóstico menores de 65 años
FUNDACIÓN PETHEMA0 个研究点开始时间: 2013年7月9日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •All patients must meet the following inclusion criteria:
- •The patient must, in the opinion of the investigator, be able to fulfill all the requirements of the assay.
- •Signed informed consent
- •Age between 18-65 years and a candidate for the realization of an autologous transplant.
- •ECOG performance status greater than 2 (or 3 if the ECOG myeloma is due to, eg. Pathologic fracture)
- •Patients newly diagnosed symptomatic multiple myeloma based on standard criteria (Appendix 6) and has not received any previous chemotherapy treatment for MM.
- •Patients with measurable disease defined by the following criteria:
- •For the secretory MM, measurable disease was defined as any measurable value monoclonal protein in serum (IgG greater or equal 10 g / L or higher IgA or equal to 5 g / L) and / or where applicable, a chain excretion light in urine greater than or equal to 200 mg/24 hours.
- •For multiple myeloma oligosecretor or secretory measurable disease defined by the presence of soft tissue plasmacytomas (not bone) determined by clinical examination or radiographic methods (eg. MRI, CT-Scan).
- •Life expectancy greater than 3 months.
- •The patient must have the following laboratory values ??within 21 days before the start of treatment (day 1, cycle 1):
- •Platelet count greater than or equal to 100 x 109 / L and absolute neutrophil count greater than or equal to 1.0 x 109 / L
- •Corrected serum calcium less than 14 mg / dL.
- •Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN).
- •Total bilirubin within normal limits.
- •Serum creatinine less than or equal to 2 mg / dL
- •Women of childbearing potential and men (including those undergoing vasectomy and if your partner is a woman of childbearing potential), must use two forms of contraception throughout treatment, during dose interruptions and for 4 weeks after receiving the last dose, and meet all the requirements of Annex 10.
- •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 460
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with any of the following exclusion criteria may not be included in the clinical trial:
- •Non-secretory myeloma without measurable plasmacytomas.
- •Patient who has previously received treatment for multiple myeloma, with the exception of pulse steroids, bisphosphonates or radiotherapy for some emergency treatment before induction.
- •Peripheral neuropathy greater than or equal to grade 2 within 21 days prior to inclusion.
- •Hypersensitivity to bortezomib, boric acid, mannitol or lenalidomide.
- •Patients who have received any investigational agent within 28 days prior to inclusion.
- •Patient who has had a myocardial infarction within 6 months prior to inclusion in the clinical trial or has a functional class III or IV according to the New York Heart Association (NYHA) heart failure, uncontrolled angina, ventricular arrhythmias not controlled or detected electrocardiographically acute ischemia or conduction system disorders.
- •Patients who are currently in another clinical trial or receiving any investigational agent.
- •Positive serology for HBV, HCV or HIV.
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