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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:
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple myeloma patients on KRd treatment
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| Name | Affiliation | Role |
|---|---|---|
| Michel Delforge | UZ Leuven Gasthuisberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Ghent | 9000 | Belgium | |||
| UZ Leuven Gasthuisberg |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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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 |
| Leuven |
| 3000 |
| Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| Clinique Saint-Pierre Ottignies | Ottignies | 1340 | Belgium |
| AZ Nikolaas | Sint-Niklaas | 9100 | Belgium |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |