Clinical trial · Observational
Observational Study of Home Administration of Carfilzomib
Observational Study of Home Administration of Carfilzomib: Feasibility, Quality of Life and Description of the Process With Related Health-care Economics
NCT04621955CI-TRIAL-00048183KARE-2withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not possible to conduct study
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Diseases | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Description of feasibility of home administration
- timeFrame
- through study completion
- description
- 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)
Secondary outcomes (13)
- measure
- Description of quality of life/satisfaction of the program
- timeFrame
- through study completion
- description
- 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"
- measure
- Description of patients acceptability
- timeFrame
- At screening
- description
- Evaluation of percentage of patients who have accepted or refused to enter the home infusion program and reasons of refusal if so.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.