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.
| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Myeloma Relapse Multiple Myeloma Refractory Multiple Myeloma | Drug: Kyprolis |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Patient Related Outcomes in Real Life Prospective Follow up Study: Carfilzomib in Combination for the Treatment of RR MM |
| Actual Study Start Date : | April 14, 2019 |
| Estimated Primary Completion Date : | April 14, 2021 |
| Estimated Study Completion Date : | April 14, 2021 |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 26, 2019 | ||||
| First Posted Date | July 2, 2019 | ||||
| Last Update Posted Date | July 2, 2019 | ||||
| Actual Study Start Date | April 14, 2019 | ||||
| Estimated Primary Completion Date | April 14, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Progression free survival [ Time Frame: 24 months ] Treatment initiation to progression or death
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Dyspnea Frequency [ Time Frame: 24 months ] Grading according to CTCAE v4.02
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Carfilzomib in Combination for the Treatment of RR MM | ||||
| Official Title | Patient Related Outcomes in Real Life Prospective Follow up Study: Carfilzomib in Combination for the Treatment of RR MM | ||||
| 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. |
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| Detailed Description |
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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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. | ||||
| Condition |
|
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| Intervention | Drug: Kyprolis
Patients receiving kyprolis (carfilzomib)
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | April 14, 2021 | ||||
| Estimated Primary Completion Date | April 14, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04004338 | ||||
| Other Study ID Numbers | 20187462 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Black Sea Hematology Association | ||||
| Study Sponsor | Black Sea Hematology Association | ||||
| Collaborators | Amgen | ||||
| Investigators |
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| PRS Account | Black Sea Hematology Association | ||||
| Verification Date | June 2019 | ||||