ISRCTN90889843已完成2 期
An open label, multicentre, randomised, parallel group phase II selection trial to identify the optimal starting dose of bendamustine (60 versus 100 mg/m2) when given in combination with thalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma
niversity of Leeds (UK)0 个研究点目标入组 94 人开始时间: 2010年7月30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
- 94
研究概览
简要总结
2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25891006 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 13/08/2012:
- •1. Aged greater than or equal to 18 years, either sex
- •2. Histologically confirmed multiple myeloma (MM) with measurable disease parameters requiring therapy for relapsed or refractory disease
- •3. Unsupported platelet count >75 x 109/L within 48 hours before registration
- •4. Absolute neutrophil count >1.5 x 109/L within 48 hours before registration. GCSF is permitted for no more than 7 days prior to registration.
- •5. Able to provide written informed consent
- •6. Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 - 3
- •7. Life expectancy at least 3 months
- •Previous inclusion criteria until 13/08/2012:
- •1. Aged greater than or equal to 18 years, either sex
- •2. Histologically confirmed multiple myeloma (MM) with measurable disease parameters requiring therapy for relapsed or refractory disease
- •3. Able to provide written informed consent
- •4. Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 - 3
- •5. Life expectancy at least 3 months
- •6. Serum bilirubin less than 1.5 times upper limit of normal
- •7. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 2.5 times upper limit of normal
排除标准
- •Current exclusion criteria as of 13/08/2012:
- •1. Pregnancy, lactation or women of child-bearing potential unwilling to use adequate and highly effective method of contraception whilst receiving treatment and for 12 months after treatment has finished as defined by the Thalidomide Pregnancy Prevention Programme
- •2. Patients with non-secretory MM
- •3. Relapsed on previous bendamustine therapy
- •4. Serum bilirubin >2.0 times ULN within 14 days before registration
- •5. Serum ALT/AST > 2.5 times ULN within 14 days before registration
- •6. Patient has a calculated or measured creatinine clearance less than 10 mL/minute within 14 days before enrolment
- •7. Patient has greater than or equal to grade 2 peripheral neuropathy within 14 days before enrolment
- •8. Any history of hypersensitivity to any of the study medications or excipients
- •9. Seropositive for human immunodeficiency virus (HIV), or active hepatitis A, B or C infection
- •10. Previous or concurrent malignancies at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (greater than or equivalent to 12 months) of other cured tumours may be entered.
- •11. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •12. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- •13. Subjects who have received an investigational medicinal product within 28 days of study entry
- •14. Steroid treatment totally greater than 160mg dexamethasone, or equivalent, in the 14 days prior to registration
- •15. Major surgery less than 30 days before start of treatment
- •16. Yellow fever vaccination within 3 months before registration
- •17. Current infections, especially involving leukocytopenia
- •Previous exclusion criteria until 13/08/2012:
- •1. Pregnancy, lactation or women of child-bearing potential unwilling to use adequate and highly effective method of contraception whilst receiving treatment and for 12 months after treatment has finished as defined by the Thalidomide Pregnancy Prevention Programme
- •2. Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, electrocardiogram (ECG) results, and physical examination that, in the Investigator's opinion, preclude entry into the study
- •3. Any history of hypersensitivity to any of the study medications or excipients
- •4. Patients with non-secretory MM
- •5. Patient has a platelet count less than 40 x 10^9/L within 14 days before enrolment
- •6. Patient has an absolute neutrophil count less than 1.0 x 10^9/L within 14 days before enrolment
- •7. Patient has a calculated or measured creatinine clearance less than 10 mL/minute within 14 days before enrolment
- •8. Patient has greater than or equal to grade 2 peripheral neuropathy within 14 days before enrolment
- •9. Seropositive for human immuno
研究者
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