EUCTR2007-000649-36-PT进行中（未招募）不适用
A phase III multicentre, randomized open-label study of Revlimid (lenalidomide) plus dexamethasone (ReDex) versus observation in patients with smoldering multiple myeloma (MM) at high risk of progression to symptomatic MM - QuiReDex
Fundación PETHEMA0 个研究点目标入组 120 人开始时间: 2008年4月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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 the investigator’s opinion, the patient must be able to fulfill all the clinical trial requirements.
- •The patient must voluntarily sign the informed consent before any study procedure that is not part of the standard of care for these patients is performed, with the patient’s knowledge that he/she may withdraw from the study at any time, without prejudice to his/her future care.
- •Aged ? 18 years.
- •The patient must be diagnosed with smoldering MM at high risk of progressing to symptomatic MM defined as follows:
- •1.Bone marrow infiltration with plasma cells (PCs) ? 10% and presence of a monoclonal component, IgG ? 3 g/dL or IgA ? 2 g/dL or Bence-Jones proteinuria > 1 g/24h and absence of lytic lesions, hypercalcaemia, renal failure (creatinine < 2 mg/dL) and anaemia (haemoglobin >10 gr/dL or not 2 gr/dL below the lower limit of normal ).
- •2.Bone marrow infiltration with PCs ? 10% OR IgG ? 3 g/dL or IgA ? 2 g/dL or Bence-Jones proteinuria > 1 g/24h (but not both together) and always in the absence of lytic lesions, hypercalcaemia, renal failure and anaemia. These patients may be included in the study if they meet the following additional criteria:
- •?A percentage of phenotypically aberrant plasma cells (PCs) within the bone marrow (BM) PC compartment (aPC/ BM PC) = 95% and immunoparesis, defined as a reduction in the levels of 1 or 2 immunoglobulins (Igs) of more than 25% compared with the normal values of the corresponding Ig
- •The patient must have an ECOG performance status ? 2 (see Appendix 5)
- •The patient must be able to attend the scheduled visits.
- •Women of childbearing potential must have a negative pregnancy test (serum or urine) within the 14 days before the starting the study drug. In addition, sexually active women must agree to use contraceptive methods (hormone contraceptives [oral, injectable or implanted], tubal ligation, intrauterine device, barrier contraceptives with spermicide or have a vasectomised partner) while receiving the study drug. Women of childbearing potential must agree to undergo pregnancy tests every 4 weeks while receiving the study drug (every 14 days for women with irregular menstrual cycles) and 4 weeks after the last dose of study drug.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any physical condition or psychiatric disorder that would prevent the patient from signing or understanding the informed consent form.
- •Previous treatment for smoldering MM
- •Pregnancy or breastfeeding.
- •Presence of lytic lesions, anaemia, renal failure or hypercalcemia
- •Any of the following laboratory abnormalities:
- •?Absolute neutrophil count (ANC) <1,000/mm3
- •?Platelet count <75,000/mm3.
- •?Serum GOT or GPT >3 x upper limit of normal
- •?Serum total bilirubin >2 x upper limit of normal
- •Prior history of neoplasm other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been disease-free for > 5 years.
- •Known hypersensitivity or prior history of uncontrollable side effects to lenalidomide or dexamethasone.
- •Major surgery within 4 weeks before inclusion in the study.
- •Any investigational drug within 30 days before inclusion in the study.
研究者
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