Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2019-04-14
2021-04-14
Brief Summary
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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.
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Detailed Description
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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.
For the primary and secondary objectives, analyses will be descriptive and include estimations; no formal hypotheses will be tested.
The study will enroll 300 participants. This multi-center trial will be conducted in Turkish Hematology clinics. The overall time to participate in this study is 12 months. Participants will be evaluated and followed-up for a period of at 12 months, until death, are lost to follow-up, or the end of the study, whichever comes first.
All hematology centers that treat MM will be eligible for participation in this study; it is likely that most participating sites will be academic institutions and/or large specialized hematology centers that treat a relatively high volume of patients with MM. It is estimated that a selection of 20 sites will be required to achieve a target of 300 patients in this study.
It is estimated that 300 RR MM patients receiving treatment will be included in the study. It is expected that this sample size will provide acceptable precision around the estimates of the primary and secondary study outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Kyprolis
Patients receiving kyprolis (carfilzomib)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Is participating in another study (observational or interventional) that prohibits participation in this study.
* Patients receiving carfilzomib more than 2 months (\>2 cycles).
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Black Sea Hematology Association
OTHER
Responsible Party
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Principal Investigators
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Mehmet Turgut, Prof
Role: PRINCIPAL_INVESTIGATOR
19 Mayıs University Faculty of Medicine
Locations
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19 Mayıs University Faculty of Medicine
Samsun, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20187462
Identifier Type: -
Identifier Source: org_study_id
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