Clinical trial NCT04621955: Observational Study of Home Administration of Carfilzomib
Official title: Observational Study of Home Administration of Carfilzomib: Feasibility, Quality of Life and Description of the Process With Related Health-care Economics
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Myeloma
Hematologic Diseases
Keywords: Home administration of chemotherapy
Relapsed and/or refractory multiple myeloma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multiple myeloma patients on KRd treatment

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Description of feasibility of home administration
timeFrame: through study completion
Secondary outcomes:
measure: Description of quality of life/satisfaction of the program
timeFrame: through study completion
measure: Description of patients acceptability
timeFrame: At screening
measure: Description of patient characteristics: performance status
timeFrame: through study completion
measure: Description of patient characteristics: professionally active at diagnosis
timeFrame: At screening
measure: Description of patient characteristics: professionally active at study entry
timeFrame: At screening
measure: Description of patient characteristics: change of professional activity during study
timeFrame: Through study completion
measure: Description of patients characteristics: extra medical consultations
timeFrame: through study completion
measure: Description of the home administration program: reason for discontinuation
timeFrame: through study completion
measure: Description of the home administration program: number of administrations
timeFrame: through study completion
measure: Description of the home administration program: patients in home infusion program
timeFrame: through study completion
measure: Description of safety: adverse events and serious adverse events (according to CTCAE 4.0)
timeFrame: through study completion
measure: Description of the cost of at home administration versus hospital administration
timeFrame: Through study completion
measure: Description of the questionnaire, completed by the physician, to assess his/her opinion on the feasibility and satisfaction of the home administration program
timeFrame: through study completion
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: CHU de Liège
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre Ottignies
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
affiliation: UZ Leuven Gasthuisberg
name: Michel Delforge
role: PRINCIPAL_INVESTIGATOR
References: