EUCTR2012-003947-31-GB进行中（未招募）1 期
Optimising Renal outcome in Myeloma renal failureA pilot study of Thalidomide, Bendamustine, and Dexamethasone (TBD) vs Bortezomib, Bendamustine, and Dexamethasone (BBD) in patients with renal failure defined as a GFR below 30 mls/ min. - OPTIMAL - Optimising Renal outcome in Myeloma renal failure
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •1. Patients attending NHS Haemato-oncology centres
- •2. Patients with newly diagnosed symptomatic myeloma and renal failure
- •3. Patients willing and able to give written informed consent
- •4. Chronic kidney disease stage 4 or 5
- •5. GFR <30mls/min
- •6. A number of patients with newly diagnosed myeloma and renal failure will have a pre-existing medical condition (hypertension, diabetes etc) causing renal damage. Where there is a medical condition (eg. hypertension, diabetes) which may cause renal damage, there must have been a further decline (=15mls/min) between previous steady state and the study screening
- •7.Female WCBP and male participants whose partner is a WCBP must be prepared to use contraception in accordance with (and consent ) to the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention Programme
- •8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10-14 days and again within 24 hours of starting study drug.
- •9. Free of prior malignancies for = 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast
- •10. In the Investigator's opinion, is able and willing to comply with all trial requirements
- •11. Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Female patient who is pregnance, lactating or planning pregnancy during the course of the trial or the female partner of a male participant planning a pregnancy during the course of the trial
- •2. Age <18 years
- •3. Known allergy to investigational drugs
- •4. Any serious medical condition or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- •5. Any of the following laboratory abnormalities:
- •- Absolute neutrophil count (ANC) <1.0 x 10(9)/L
- •- Platelet count <75 x 10(9)/L
- •- Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal
- •5. Use of any standard/experimental anti-myeloma drug therapy 14 days prior to trial entry
- •6. CKD <4
- •7. Intention to use a physical method of serum free light chain removal such as plasma exchange or high cut off dialysis
- •8. Grade 2 neuropathy or more will preclude use of thalidomide and bortezomib
- •9. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
研究者
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