Observational Study of Home Administration of Carfilzomib (KARE-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04621955|
Recruitment Status : Withdrawn (Not possible to conduct study)
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
|Condition or disease|
|Multiple Myeloma Hematologic Diseases|
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|
|Actual Enrollment :||0 participants|
|Official Title:||Observational Study of Home Administration of Carfilzomib: Feasibility, Quality of Life and Description of the Process With Related Health-care Economics|
|Estimated Study Start Date :||June 2017|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||November 2018|
- Description of feasibility of home administration [ Time Frame: 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)
- Description of quality of life/satisfaction of the program [ Time Frame: through study completion ]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"
- Description of patients acceptability [ Time Frame: At screening ]Evaluation of percentage of patients who have accepted or refused to enter the home infusion program and reasons of refusal if so.
- Description of patient characteristics: performance status [ Time Frame: through study completion ]Description of performance status (via Karnofsky scaling)
- Description of patient characteristics: professionally active at diagnosis [ Time Frame: At screening ]Percentage of patients professionally active at time of diagnosis of multiple myeloma
- Description of patient characteristics: professionally active at study entry [ Time Frame: At screening ]Percentage of patients professionally active at study entry
- Description of patient characteristics: change of professional activity during study [ Time Frame: Through study completion ]Percentage of patients with change in professional activity during study
- Description of patients characteristics: extra medical consultations [ Time Frame: through study completion ]Description of extra medical consultations (general practitioner, hospitalisations, REMEDUS) and reasons for these visits
- Description of the home administration program: reason for discontinuation [ Time Frame: through study completion ]Description of reason of discontinuation of home administration program
- Description of the home administration program: number of administrations [ Time Frame: through study completion ]Description of number of home administrations received vs planned per patient and total population + reasons of missed doses
- Description of the home administration program: patients in home infusion program [ Time Frame: through study completion ]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
- Description of safety: adverse events and serious adverse events (according to CTCAE 4.0) [ Time Frame: through study completion ]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
- Description of the cost of at home administration versus hospital administration [ Time Frame: Through study completion ]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.
- Description of the questionnaire, completed by the physician, to assess his/her opinion on the feasibility and satisfaction of the home administration program [ Time Frame: through study completion ]Description of the survey for the principal investigator (completed before and after the study) to give feedback on the home administration program
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621955
|Gent, Belgium, 9000|
|UZ Leuven Gasthuisberg|
|Leuven, Belgium, 3000|
|CHU de Liège|
|Liège, Belgium, 4000|
|Clinique Saint-Pierre Ottignies|
|Ottignies, Belgium, 1340|
|Sint-Niklaas, Belgium, 9100|
|Principal Investigator:||Michel Delforge||UZ Leuven Gasthuisberg|