Multiple MyelomaKARE-2NCT04621955
Observational Study of Home Administration of Carfilzomib
An observational study of Multiple Myeloma and Hematologic Diseases, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.
Trial summary
The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Hematologic Diseases
- How many people
- 0 participants
- Where
- 5 sitesBelgium
- Study dates
- Jun 2017to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple myeloma patients on KRd treatment
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
CHU de Liège
Liège, 4000
Clinique Saint-Pierre Ottignies
Ottignies, 1340
AZ Nikolaas
Sint-Niklaas, 9100
About this study
Official title: Observational Study of Home Administration of Carfilzomib: Feasibility, Quality of Life and Description of the Process With Related Health-care Economics
The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients.
Read the 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.
- Conditions
- Multiple Myeloma, Hematologic Diseases
- Keywords
- Home administration of chemotherapy, Relapsed and/or refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion
Secondary outcomes (13)
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"
Measured: through study completion
Description of patients acceptability
Evaluation of percentage of patients who have accepted or refused to enter the home infusion program and reasons of refusal if so.
Measured: At screening
Description of patient characteristics: performance status
Description of performance status (via Karnofsky scaling)
Measured: through study completion
Description of patient characteristics: professionally active at diagnosis
Percentage of patients professionally active at time of diagnosis of multiple myeloma
Measured: At screening
Description of patient characteristics: professionally active at study entry
Percentage of patients professionally active at study entry
Measured: At screening
Description of patient characteristics: change of professional activity during study
Percentage of patients with change in professional activity during study
Measured: Through study completion
Description of patients characteristics: extra medical consultations
Description of extra medical consultations (general practitioner, hospitalisations, REMEDUS) and reasons for these visits
Measured: through study completion
Description of the home administration program: reason for discontinuation
Description of reason of discontinuation of home administration program
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study startJun 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Not possible to conduct study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Delforge, Principal investigator, UZ Leuven Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621955
- Sponsor's protocol ID
- 20167745
- Acronym
- KARE-2
- Status last verified
- Nov 2020
- First submitted
- 2 May 2017
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Home Administration of Carfilzomib: Feasibility, Quality of Life and Description of the Process With Related Health-care Economics
- ClinicalTrials.gov ID
- NCT04621955
- Acronym / sponsor ID
- KARE-2 / 20167745
- Conditions
- Multiple Myeloma, Hematologic Diseases
- Keywords
- Home administration of chemotherapy, Relapsed and/or refractory multiple myeloma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not possible to conduct study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple myeloma patients on KRd treatment
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
13 secondary outcomes
Description of quality of life/satisfaction of the program
Time frame: through study completion
Description of patients acceptability
Time frame: At screening
Description of patient characteristics: performance status
Time frame: through study completion
Description of patient characteristics: professionally active at diagnosis
Time frame: At screening
Description of patient characteristics: professionally active at study entry
Time frame: At screening
Description of patient characteristics: change of professional activity during study
Time frame: Through study completion
Description of patients characteristics: extra medical consultations
Time frame: through study completion
Description of the home administration program: reason for discontinuation
Time frame: through study completion
Description of the home administration program: number of administrations
Time frame: through study completion
Description of the home administration program: patients in home infusion program
Time frame: through study completion
Description of safety: adverse events and serious adverse events (according to CTCAE 4.0)
Time frame: through study completion
Description of the cost of at home administration versus hospital administration
Time frame: 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
Time frame: through study completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Delforge principal investigator
UZ Leuven Gasthuisberg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Hematologic Diseases, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of feasibility of home administration (time frame: through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.