ISRCTN11933044已完成2 期
A randomised phase II clinical trial using targeted radiotherapy delivered by an yttrium-90 radio-labelled Anti-CD66 monoclonal antibody with high dose melphalan compared to melphalan alone, prior to autologous stem cell transplantation for multiple myeloma
Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 25 人开始时间: 2007年5月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically proven multiple myeloma
- •2. In partial remission (PR) after chemotherapy and before priming therapy for stem cell mobilisation
- •3. Aged greater than 18 years
- •4. Life expectancy of at least 24 weeks
- •5. World Health Organization (WHO) performance status of less than two
- •6. Haematological and biochemical indices (these measurements must be performed within one week prior to the patient going on study):
- •6.1. Haemoglobin (Hb) greater than or equal to 9.0 g/dl
- •6.2. Neutrophils greater than or equal to 1.5 x 10^9/L
- •6.3. Platelets (Plts) greater than or equal to 50 x 10^9/L
- •7. Any of the following abnormal baseline liver function tests:
- •7.1. Serum bilirubin less than or equal to 1.5 x upper normal limit
- •7.2. Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) less than or equal to 2.5 x Upper Limit of Normal (ULN)
- •8. The following abnormal baseline renal function test:
- •8.1. Calculated creatinine clearance greater than or equal to 50 ml/min (uncorrected value), or
- •8.2. Isotope clearance measurement greater than or equal to 50 ml/min
- •9. No concurrent or recent (within four weeks) chemotherapy for the underlying haematological condition (excluding cyclophosphamide priming for stem cell harvest). This does not include thalidomide which is permitted
- •10. Although the bone marrow (BM) remission status is not important, patients must have cellularity greater than 20%
- •11. 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
- •12. Patients must be negative for human anti-mouse antibodies (HAMA)
- •13. Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented
- •14. Female patients of child-bearing potential are eligible, provided they have a negative serum pregnancy test prior to enrolment and agree to use medically approved contraceptive precautions for four weeks prior to entering the trial, during the trial and for six months afterwards
- •15. Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards
排除标准
- •1. Radiotherapy (except for localised pain control), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks
- •2. All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade one toxicities which in the opinion of the Investigator should not exclude the patient.
- •3. Patients with BM cellularity less than 20%
- •4. Patients who test positive for HAMA
- •5. Previous high dose therapy and autologous stem cell transplant
- •6. Patients in complete remission (CR) after chemotherapy and prior to autologous peripheral blood stem cell transplantation (APBSCT)
- •7. Pregnant and lactating women are excluded
- •8. Major thoracic and/or abdominal surgery in the preceding three to four weeks from which the patient has not yet recovered
- •9. Patients who are high medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection
- •10. Patients with any other condition that, in the Investigator?s opinion, would not make the patient a good candidate for the clinical trial
- •11. Patients known to be serologically positive for hepatitis B, C or human immunodeficiency virus (HIV)
- •12. History of allergy, in particular a history of allergy to rodents or rodent proteins
- •13. History of eczema and/or asthma
- •14. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease
- •15. Patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health
- •16. Less than 4 x 10^6 CD34 positive cells per kg body weight
研究者
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