Observational Study of Home Administration of Carfilzomib (KARE-2)

Universitaire Ziekenhuizen KU Leuven

Status: Withdrawn

Conditions: Multiple Myeloma; Hematologic Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT04621955

20167745

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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