Carfilzomib in Combination for the Treatment of RR MM

June 27, 2019 updated by: Black Sea Hematology Association

Patient Related Outcomes in Real Life Prospective Follow up Study: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey
        • Recruiting
        • 19 Mayıs University Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 24 months
Treatment initiation to progression or death
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea Frequency
Time Frame: 24 months
Grading according to CTCAE v4.02
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Black Sea Hematology Association

Collaborators

Amgen

Investigators

  • Principal Investigator: Mehmet Turgut, Prof, 19 Mayıs University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 14, 2019

Primary Completion (ANTICIPATED)

April 14, 2021

Study Completion (ANTICIPATED)

April 14, 2021

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (ACTUAL)

July 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20187462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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