The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients.
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.
Study Type
OBSERVATIONAL
UZ Gent
Ghent, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
CHU de Liège
Liège, Belgium
Clinique Saint-Pierre Ottignies
Ottignies, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
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)
Time frame: through study completion
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"
Time frame: 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.
Time frame: At screening
Description of patient characteristics: performance status
Description of performance status (via Karnofsky scaling)
Time frame: through study completion
Description of patient characteristics: professionally active at diagnosis
Percentage of patients professionally active at time of diagnosis of multiple myeloma
Time frame: At screening
Description of patient characteristics: professionally active at study entry
Percentage of patients professionally active at study entry
Time frame: At screening
Description of patient characteristics: change of professional activity during study
Percentage of patients with change in professional activity during study
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Time frame: Through study completion
Description of patients characteristics: extra medical consultations
Description of extra medical consultations (general practitioner, hospitalisations, REMEDUS) and reasons for these visits
Time frame: through study completion
Description of the home administration program: reason for discontinuation
Description of reason of discontinuation of home administration program
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: through study completion