Observational Study of Home Administration of Carfilzomib

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients.

Detailed Description
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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. If the patient doesn't accept to participate in the home administration program: -The patient can agree on one-time collection of data: patient characteristics (date of birth+gender) and reason for refusal to the home administration program.

Official Title
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Observational Study of Home Administration of Carfilzomib: Feasibility, Quality of Life and Description of the Process With Related Health-care Economics

Conditions
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Multiple Myeloma, Hematologic Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of feasibility of home administration | 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) | through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of quality of life/satisfaction of the program | Quality of life and satisfaction of the program during home administration of carfilzomib evaluation via a validated QoL questionnaire on day 1 of each cycle | through study completion | 
| Description of patients acceptability | Evaluation of percentage of patients who have accepted or refused to enter the home infusion program and reasons of refusal if so. | At screening | 
| Description of patient characteristics: performance status | Description of performance status (via Karnofsky scaling) | through study completion | 
| Description of patient characteristics: professionally active at diagnosis | Percentage of patients professionally active at time of diagnosis of multiple myeloma | At screening | 
| Description of patient characteristics: professionally active at study entry | Percentage of patients professionally active at study entry | At screening | 
| Description of patient characteristics: change of professional activity during study | Percentage of patients with change in professional activity during study | Through study completion | 
| Description of patients characteristics: extra medical consultations | Description of extra medical consultations (general practitioner, hospitalisations, REMEDUS) and reasons for these visits | through study completion | 
| Description of the home administration program: reason for discontinuation | Description of reason of discontinuation of home administration program | through study completion | 
| Description of the home administration program: number of administrations | Description of number of home administrations received vs planned per patient and total population + reasons of missed doses | through study completion | 
| Description of the home administration program: patients in home infusion program | Percentage of patients still in the home administration program after 2 cycles in the hospital and 4 cycles combined at hospital/at home (full population), whatever the reason for discontinuation | through study completion | 
| Description of safety: adverse events and serious adverse events (according to CTCAE 4.0) | Incidence, relationship and severity of adverse events, serious adverse events, adverse events leading to discontinuation and adverse events leading to treatment interruption according to CTCAE v4.03 criteria; safety will be reported at home and in the hospital | through study completion | 
| Description of the cost of at home administration versus hospital administration | Description of the cost of at home administration versus hospital administration. The cost will be carried out taking into consideration the laws governing the Belgian health care system, in which 100% of cancer medical costs are funded by the government (no expense is charged to the patient), and included all expenditures. | 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 | Description of the survey for the principal investigator (completed before and after the study) to give feedback on the home administration program | through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home administration of chemotherapy, Relapsed and/or refractory multiple myeloma