Carfilzomib in Combination for the Treatment of RR MM
Carfilzomib in Combination for the Treatment of RR MM
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.
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.

 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.
Inclusion Criteria:

 -  18 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

 Exclusion Criteria:

 -  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).