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Carfilzomib in Combination for the Treatment of RR MM

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ClinicalTrials.gov Identifier: NCT04004338
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Black Sea Hematology Association

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
 (submitted: June 27, 2019)
Progression free survival [ Time Frame: 24 months ]
Treatment initiation to progression or death
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 27, 2019)
Dyspnea Frequency [ Time Frame: 24 months ]
Grading according to CTCAE v4.02
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • Multiple Myeloma
  • Relapse Multiple Myeloma
  • Refractory Multiple Myeloma
Intervention Drug: Kyprolis
Patients receiving kyprolis (carfilzomib)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 27, 2019)
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:

  • 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mehmet Turgut, Prof +905324412859 turgutmehmet@yahoo.com
Contact: İlker Kürkçü +905326354515 ilker.kurkcu@sentez-cro.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Black Sea Hematology Association
Study Sponsor Black Sea Hematology Association
Collaborators Amgen
Investigators
Principal Investigator: Mehmet Turgut, Prof 19 Mayıs University Faculty of Medicine
PRS Account Black Sea Hematology Association
Verification Date June 2019