REal Life, Retrospective Study of BOrtezomib Use as secoND Treatment for Myeloma Patients Previously Exposed to Bortezomib-based Therapies as First Line
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Adverse events
研究概览
简要总结
This observational, non-interventional, retrospective, multicenter, national study focuses on collecting information about the effectiveness and safety of bortezomib re-use at first relapse in MM patients already treated in their first line with a bortezomib-based regimen, re-challenged with the same drug according to current clinical practice and/or Italian SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations.
Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in Italy. Approximately, data of up to 100 patients will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients satisfying all of the following criteria will be enclosed in the study:
- •Age ≥ 18 years old
- •Patients with documented multiple myeloma that received bortezomib-based regimens as first line treatment (both in clinical practice or clinical trials) even if followed by ASCT (Autologous stem cell transplantation) and that after their first line treatment's clinical or biochemical relapse received again a bortezomib-based treatment according to current clinical practice and/or Italian Societies of Hematology (SIE), Experimental Hematology (SIES) and Transplantation (GITMO), International Myeloma Working group (IMWG) and/or National Cancer Comprehensive Cancer Network (NCCN) guidelines/treatment recommendations.
- •Signed Informed Consent form if feasible
排除标准
- •Patients not treated with bortezomib as first line therapy and/or second line therapy
- •Patients with more than one relapse before bortezomib re-use
- •Patients unable to understand and sign Informed Consent form (see exceptions listed in section 8 "Informed consent")
- •Patients who received bortezomib at relapse in combination with any investigational drug not-approved.
结局指标
主要结局
Adverse events
时间窗: March,31, 2016
Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria)
Response rate
时间窗: March, 31, 2016
International Myeloma Study Group Criteria
次要结局
- Secondary primary malignancies(March, 31, 2016)
- Overall survival(March, 31, 2016)
- Progression free survival 1 and 2(March, 31, 2016)
- Time to next treatment(March, 31, 2016)
研究者
Pellegrino Musto
Scientific Director
IRCCS Centro di Riferimento Oncologico della Basilicata