EUCTR2006-003424-12-GB进行中（未招募）1 期
A randomised phase II clinical trial using targeted radiotherapy delivered by an Yttrium-90 radiolabelled Anti-CD66 monoclonal antibody with high dose melphalan compared to melphalan alone, prior to autologous stem cell transplantation for multiple myeloma - TARGETED RADIOTHERAPY WITH CONDITIONING PRIOR TO HAEMATOPOIETIC STEM CELL TRANSPLANTATIO
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2007年1月16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
- 90
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
- •Histologically or cytologically proven multiple myeloma.
- •In PR after chemotherapy and before priming therapy for stem cell mobilization.
- •Age greater than 18 years.
- •Life expectancy of at least 24 weeks.
- •World Health Organisation (WHO) performance status of < 2 (Appendix 1).
- •Haematological and biochemical indices (These measurements must be performed within one week prior to the patient going on study.)
- •-Haemoglobin (Hb) = 9.0 g/dl
- •-neutrophils = 1.5 x 109/L
- •-platelets (Plts) = 50 x 109/L
- •Any of the following abnormal baseline liver function tests :
- •-Serum bilirubin = 1.5 x upper normal limit
- •-Alanine amino-transferase (ALT)
- •-and/or aspartate amino-transferase (AST) = 2.5 x upper limit of normal (ULN) unless due to tumour in which case up to 5 x ULN is permissible
- •The following abnormal baseline renal function test:
- •-calculated creatinine clearance = 50 ml/min (uncorrected value)
- •-or isotope clearance measurement = 50ml/min
- •No concurrent or recent (within 4 weeks) chemotherapy for the underlying haematological condition (excluding cyclophosphamide priming for stem cell harvest). This does not include thalidomide which is permitted.
- •Although the BM remission status is not important, patients must have cellularity > 20%.
- •Patients must have sufficient stem cells in cryo-storage for two transplant procedures, this is in case graft failure occurs as a result of therapy.
- •Patients must be negative for human anti-mouse antibodies (HAMA).
- •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
- •Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment.
- •All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and LRF should not exclude the patient.
- •Patients with BM cellularity < 20%.
- •Patients who test positive for HAMA.
- •Previous high dose therapy and autologous stem cell transplant.
- •Patients in CR after chemotherapy and prior to APBSCT.
- •Pregnant and lactating women are excluded.
- •Major thoracic and/or abdominal surgery in the preceding three to four weeks from which the patient has not yet recovered.
- •Patients who are high medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.
- •Patients with any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
- •Patients known to be serologically positive for Hepatitis B, C or HIV.
- •History of Allergy. In particular a history of allergy to rodents or rodent proteins.
- •History of eczema, asthma.
- •Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease (refer to Appendix 5)
- •Patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health.
- •Less than 4 x 106 CD34 positive cells per kg body weight.
研究者
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