A Disease Registry Encompassing the Care Of Patients With Multiple Myeloma on Panobinostat (RECOMM)

June 12, 2023 updated by: zr Pharma & GmbH

A Disease Registry Encompassing the Care of Patients With Multiple Myeloma on Panobinostat (RECOMM)

This study aims to describe current treatment patterns in the real-world setting among patients with multiple myeloma who are initiating treatment with (or changing treatment to) panobinostat and explore the associations with baseline patient characteristics, healthcare resource utilization, and clinical outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

248

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

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • American Health Network Indiana
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Southern Nevada Cancer Research Foundation and Optum Cancer Care
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Oncology Specialists of Charlotte
      • Huntersville, North Carolina, United States, 28078
        • Southern Oncology Specialists
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Coastal Cancer Center
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Blood and Cancer Care Associates

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

Sampling Method

Non-Probability Sample

Study Population

The study population will be any adult who is clinically diagnosed with multiple myeloma who is actively taking panobinostat.

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • At least 18 years of age
  • Clinical diagnosis of multiple myeloma that meets published diagnostic criteria
  • Initiating panobinostat within 60 days of enrollment
  • ECOG performance status 0-1
  • Availability of documentation from the patient's medical records regarding previous myeloma treatment, response, and duration of response
  • Willing and able to complete the PRO questionnaire

Exclusion Criteria:

  • Diagnosed with any B-cell malignancy other than myeloma
  • Estimated life expectancy <6 months
  • Currently enrolled in any interventional clinical trial at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry)

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
Response to treatment
Time Frame: 24 months
Looking for patient reproted response to treatment with panobinostat
24 months

Collaborators and Investigators

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

Sponsor

zr Pharma & GmbH

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)

November 4, 2019

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20192475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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