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

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ClinicalTrials.gov Identifier: NCT04621955
Recruitment Status : Withdrawn (Not possible to conduct study)
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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

Condition or disease
Multiple Myeloma Hematologic Diseases

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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"

  2. 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.

  3. Description of patient characteristics: performance status [ Time Frame: through study completion ]
    Description of performance status (via Karnofsky scaling)

  4. Description of patient characteristics: professionally active at diagnosis [ Time Frame: At screening ]
    Percentage of patients professionally active at time of diagnosis of multiple myeloma

  5. Description of patient characteristics: professionally active at study entry [ Time Frame: At screening ]
    Percentage of patients professionally active at study entry

  6. 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

  7. 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

  8. Description of the home administration program: reason for discontinuation [ Time Frame: through study completion ]
    Description of reason of discontinuation of home administration program

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Multiple myeloma patients on KRd treatment
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

Information from the National Library of Medicine

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


Locations
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Belgium
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
CHU de Liège
Liège, Belgium, 4000
Clinique Saint-Pierre Ottignies
Ottignies, Belgium, 1340
AZ Nikolaas
Sint-Niklaas, Belgium, 9100
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Michel Delforge UZ Leuven Gasthuisberg
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04621955    
Other Study ID Numbers: 20167745
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Home administration of chemotherapy
Relapsed and/or refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Hematologic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases