Observational Study of Home Administration of Carfilzomib: Feasibility, Quality of Life and Description of the Process With Related Health-care Economics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Description of feasibility of home administration
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients.
详细描述
In this observational study, the feasibility of an at home administration program for carfilzomib will be evaluated in patients with relapsed and/or refractory multiple myeloma having already received a minimum of 2 and a maximum of 6 full cycles of KRd (carfilzomib - lenalidomide - dexamethasone) in the hospital.
One treatment cycle of KRd consists of a 28-day period. Carfilzomib is administered intravenously as a 10 minute infusion, on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15 and 16), followed by a 12-day rest period (days 17 - 28). In combination with carfilzomib, lenalidomide is administered orally on days 1-21 and dexamethasone is administered orally on days 1, 8, 15 and 22 of the 28-day cycles.
Multiple myeloma is characterized by a recurring pattern of remission and relapse. Given the need for chronic treatment and good adherence, convenience and quality of life of the patients become important factors as well. As the majority of the multiple myeloma patients are elderly and the treatment schedule requires many hospital visits, this treatment schedule may impact the social and familial life of the patient.
If the patient accepts to participate in the home administration program:
- Administration of carfilzomib during cycle 1 and 2 will be performed in the hospital
- During cycle 3 until 6, carfilzomib will be administered on day 1 and15 in the hospital, while there will be home administration on days 2, 8, 9 and 16.
- On day 1 of each cycle, there will be asked to the patient to complete a short questionnaire about the quality of life and patients satisfaction during the home administration program of carfilzomib.
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
- •Age ≥ 18 years
- •Ability to understand the informed consent and willingness to provide an informed consent signature
- •Signed and dated written informed consent available (for participation in the home administration program or for agreement on data-collection in case of refusal to participate (reasons for refusal))
- •Diagnosis of a relapsed and/or refractory multiple myeloma (refractory meaning nonresponsive (stable or progressive disease) during treatment or disease progression within 60 days of treatment discontinuation)
- •Patient on KRd treatment (according to reimbursement criteria) having already received a minimum of 2 and a maximum of 6 full cycles of KRd in the hospital
- •Patient with good tolerance of KRd and expected to receive ≥ 6 cycles based on clinical assessment of the treating physician
- •Patient willing to receive at home intravenous administration of carfilzomib (only for patients who accepted the home administration program of the study)
排除标准
- •Lactating or pregnant females
- •Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Program of lenalidomide are met and unless use effective contraception measures during and for one month following treatment. Male patients should use contraception and refrain form sperm donation for at least 90 days after the last dose of carfilzomib.
- •Patients who already received carfilzomib home administration
- •Any contra-indication for continuation of treatment with carfilzomib
结局指标
主要结局
Description of feasibility of home administration
时间窗: through study completion
Percentage of patients still in the home administration program 4 cycles mixed home/hospital and who did not discontinue due to AE (adverse event) or PD (progressive disease)
次要结局
- Description of the home administration program: patients in home infusion program(through study completion)
- Description of patients acceptability(At screening)
- Description of patient characteristics: performance status(through study completion)
- Description of patient characteristics: professionally active at diagnosis(At screening)
- Description of the home administration program: number of administrations(through study completion)
- Description of the cost of at home administration versus hospital administration(Through study completion)
- Description of safety: adverse events and serious adverse events (according to CTCAE 4.0)(through study completion)
- Description of patient characteristics: change of professional activity during study(Through study completion)
- Description of patients characteristics: extra medical consultations(through study completion)
- Description of quality of life/satisfaction of the program(through study completion)
- Description of patient characteristics: professionally active at study entry(At screening)
- Description of the home administration program: reason for discontinuation(through study completion)
- Description of the questionnaire, completed by the physician, to assess his/her opinion on the feasibility and satisfaction of the home administration program(through study completion)