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Trial record 72 of 183 for:    carfilzomib OR pr-171

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

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.


Condition or disease Intervention/treatment
Multiple Myeloma Relapse Multiple Myeloma Refractory Multiple Myeloma Drug: Kyprolis

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
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Carfilzomib


Intervention Details:
  • Drug: Kyprolis
    Patients receiving kyprolis (carfilzomib)


Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 24 months ]
    Treatment initiation to progression or death


Secondary Outcome Measures :
  1. Dyspnea Frequency [ Time Frame: 24 months ]
    Grading according to CTCAE v4.02



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004338


Contacts
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Contact: Mehmet Turgut, Prof +905324412859 turgutmehmet@yahoo.com
Contact: İlker Kürkçü +905326354515 ilker.kurkcu@sentez-cro.com

Locations
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Turkey
19 Mayıs University Faculty of Medicine Recruiting
Samsun, Turkey
Contact: Mehmet Turgut, Prof    +905324412859    turgutmehmet@yahoo.com   
Sponsors and Collaborators
Black Sea Hematology Association
Amgen
Investigators
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Principal Investigator: Mehmet Turgut, Prof 19 Mayıs University Faculty of Medicine

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Responsible Party: Black Sea Hematology Association
ClinicalTrials.gov Identifier: NCT04004338     History of Changes
Other Study ID Numbers: 20187462
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Black Sea Hematology Association:
Carfilzomib
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases