ISRCTN60123120已完成3 期
A phase III study to determine the role of a second autologous stem cell transplant as consolidation therapy in patients with relapsed multiple myeloma following prior high dose chemotherapy and autologous stem cell rescue
The Leeds Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 293 人开始时间: 2007年1月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 293
研究概览
简要总结
2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24948586 results (added 10/04/2019) 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23298856 results (added 10/04/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26827659 results (added 10/04/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27374467 results (added 10/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria amended as of 24/08/2007:
- •Registration:
- •1. Diagnosed with symptomatic (including non-secretory) Multiple Myeloma (MM) previously treated with standard chemotherapy and autologous transplantation
- •2. Requiring therapy for first Progressive Disease (PD) (where PD is determined according to the International uniform response criteria for myeloma. Patients previously immunofixation negative who are now immunofixation positive need to demonstrate a greater than 5 g/liter absolute increase in paraprotein to be eligible for inclusion)
- •3. Demonstrate PD requiring treatment at least 18 months from time of first transplant
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •5. Aged at least 18 years
- •6. Adequate full blood count within 14 days before registration:
- •a. Platelet count greater than or equal to 50 x 109/L
- •b. Absolute Neutrophil Count (ANC) greater than or equal to 1 x 109/L
- •7. Adequate renal function within 14 days before registration:
- •a. Creatinine clearance greater than or equal to 30 ml/min
- •8. Adequate hepatobiliary function within 14 days before registration:
- •a. Total bilirubin less than 2 x Upper Limit of Normal (ULN)
- •b. ALanine aminoTransferase (ALT) or ASpartate aminoTransferase (AST) less than 2.5 x ULN
- •9. Adequate pulmonary function within 14 days before registration:
- •a. No evidence of a history of pulmonary disease. If a history, then KCO/DLCO (Carbon Monoxide diffusion in the lung) greater than or equal to 50% and/or no requirement for supplementary continuous oxygen
- •10. Adequate cardiac function within 14 days before registration:
- •a. Left Ventricular Ejection Fraction (LVEF) greater than or equal to 40% by ElectroCardioGram (ECG) or Multiple Gated Acquisition (MUGA) scan
- •11. If female and of childbearing potential, must have a negative pregnancy test (either serum or urine Human Choronic Gonadotropin [HCG]) within 24 hours prior to start of PAD therapy
- •12. Provided written informed consent
- •Randomisation:
- •1. Registered into the Myeloma X Relapse (Intensive) trial and received 2-4 cycles of PAD re-induction chemotherapy according to the protocol
- •2. Responded ([s]Complete Response [CR] or [VG] Partial Response [PR]) or have Stable Disease (SD), following PAD re-induction chemotherapy according to the International Uniform Response Criteria for myeloma
- •3. Adequate stem cell mobilisation defined as greater than or equal to 2 x 106 CD34+ cells/kg or greater than or equal to 2 x 108 Peripheral Blood Mononuclear Cells (PBMC)/kg available for transplantation (including cells stored from a previous harvest)
- •4. Adequate full blood count within 14 days before randomisation:
- •a. Platelet count greater than or equal to 50 x 109/L
- •b. ANC greater than or equal to 1 x 109/L
- •5. Adequate renal function within 14 days before randomisation:
- •a. Creatinine clearance greater than or equal to 30 ml/min
- •6. Adequate hepatobiliary function within 14 days before randomisation:
- •a. Total bilirubin less than 2 x ULN
排除标准
- •Exclusion criteria amended as of 24/08/2007:
- •Registration:
- •1. Received therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone up to a maximum of 200 mg. (Radiotherapy since pervious transplant sufficient to alleviate or control pain of local invasion is permitted. Patients who have received hemi-body radiation or similar since previous transplant will not be eligible)
- •2. ECOG Performance Status 3-4
- •3. Greater than or equal to Grade 2 peripheral neuropathy within 14 days before registration
- •4. Known HIV or Hepatitis B/C seropositivity (testing is not required for the trial)
- •5. Use of any investigational drug within 4 weeks prior to registration, or scheduled to receive any investigational drug during the course of the study
- •6. Known resistance to combined bortezomib, doxorubicin and dexamethasone (PAD) therapy
- •7. Known history of allergy contributable to compounds containing boron or mannitol
- •8. Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient's participation in this study
- •9. Previous or concurrent malignancies at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with remote histories (>5 years) of other cured tumours may be entered
- •10. Pregnant or breast feeding
- •11. Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment if female of childbearing potential, or male whose partner is a female of childbearing potential unless they are surgically sterile
- •Randomisation:
- •1. Received any therapy for their relapsed disease, other than local radiotherapy or protocol PAD treatment, prior to randomisation. (Radiotherapy sufficient to alleviate or control pain of local invasion is permitted. Patients who have received hemi-body radiation or similar since previous transplant will not be eligible)
- •2. Progressive disease, according to International Uniform Response Criteria for myeloma following PAD re-induction therapy or stem cell mobilisation
- •3. Any contra-indication to protocol treatment that would make the patient ineligible
- •Exclusion criteria provided at time of registration:
- •Registration:
- •1. Patients who have received therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange or dexamethasone up to a maximum of 200 mg
- •2. Females of child-bearing potential without a negative pregnancy test, immediately prior to the start of PAD therapy and/or unwilling to use barrier contraceptive precautions throughout the study or who are pregnant or breast-feeding
- •3. Non-secretory MM
- •4. Performance status three to four (ECOG)
- •5. Platelet count less than 50 x 10^9/L within 14 days before enrolment
- •6. Absolute neutrophil count less than 1.0 x 10^9/L within 14 days before enrolment
- •7. Grade two peripheral neuropathy within 14 days before enrolment
- •8. Presence of severe irreversible renal, hepatic, pulmonary or cardiac disease such as:
- •a. Total bilirubin,
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