Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
研究概览
简要总结
The purpose of this pilot study is to examine changes in patient-reported outcomes in patients with RRMM receiving triple therapy with ixazomib in combination with LenDex in a real world setting as well as to analyze clinical outcomes and safety of this treatment modality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients with confirmed diagnosis of RRMM
- •At least 18 years of age at the time of treatment start
- •Patients who have received at least one prior therapy and who are suitable for treatment with ixazomib in combination with LenDex
- •Patients who gave informed consent
- •Patients who are capable to fill out questionnaires
- •Patients with expected life duration of at least 6 months
排除标准
- •Patients currently enrolled in any other clinical trials
- •Patients with contraindications to ixazomib in accordance with instruction for use.
结局指标
主要结局
Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
时间窗: Assessment of QoL changes will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start as compared to baseline
The change in QoL will be assessed as the difference in QoL means by scales of RAND SF-36 between any time-points during 18 mos of treatment and additionally as the difference in QoL means at any time-point as compared to baseline.
Changes in symptom severity while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
时间窗: Assessment of changes in symptom severity will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start
The change in symptom severity will be assessed as the difference in the severity of each ESAS-R scale, the symptom distress score and the severity of NRS for assessing tingling hands/feet between any time-points during 18 mos of treatment and additionally at each time-point as compared with their baseline value. The proportion of patients with ≥1 point improvement on ESAS-R scale and on NRS for assessing tingling hands/feet at each time-point will be analyzed as well
Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone
时间窗: Assessment will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start
Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone will be assessed at each time-point during treatment with ixazomib in combination with lenalidomide and dexamethasone
次要结局
- Overall response rates and duration of response to treatment with ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)
- Overall survival (OS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)
- Frequency of adverse events (AEs)/serious AEs in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)
- Progression free survival (PFS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)