Carfilzomib in Combination for the Treatment of RR MM
Patient Related Outcomes in Real Life Prospective Follow up Study: Carfilzomib in Combination for the Treatment of RR MM
1 other identifier
observational
300
1 country
1
Brief Summary
Carfilzomib is approved in Turkey for the treatment of adult relapsed multiple myeloma patients who have received at least one prior treatment. It is approved for use in combination with lenalidomide and dexamethasone (KRd) in and with dexamethasone alone (Kd). The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, prior therapeutic regimen chosen, and clinical outcomes in participants with relapsed/refractory (R/R) multiple myeloma (MM) who receive Carfilzomib combination treatment. Real-world evidence is crucial to understand how carfilzomib-based regimens are used in practice and in relation to local prescribing information. This is a prospective, non-interventional, observational study. The study population will include patients with relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy at participating clinical sites in Turkey.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2019
CompletedFirst Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2021
CompletedJuly 2, 2019
June 1, 2019
2 years
June 26, 2019
June 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Treatment initiation to progression or death
24 months
Secondary Outcomes (1)
Dyspnea Frequency
24 months
Interventions
Patients receiving kyprolis (carfilzomib)
Eligibility Criteria
The study population will include patients with relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy at participating clinical sites in Turkey.
You may qualify if:
- years and older
- Relapsed/refractory MM patients who have received 1 to 3 prior lines of therapy
- Is willing and able to sign informed consent (ICF) to participate
- Patients receiving carfilzomib equal or less than 2 months (≤2 cycles) according to regulatory approvals
You may not qualify if:
- Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for case report form (eCRF) completion.
- Is participating in another study (observational or interventional) that prohibits participation in this study.
- Patients receiving carfilzomib more than 2 months (\>2 cycles).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Black Sea Hematology Associationlead
- Amgencollaborator
Study Sites (1)
19 Mayıs University Faculty of Medicine
Samsun, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehmet Turgut, Prof
19 Mayıs University Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2019
First Posted
July 2, 2019
Study Start
April 14, 2019
Primary Completion
April 14, 2021
Study Completion
April 14, 2021
Last Updated
July 2, 2019
Record last verified: 2019-06