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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150289
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
SecuraBio

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Farydak

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Disease Registry Encompassing the Care of Patients With Multiple Myeloma on Panobinostat (RECOMM)
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma


Intervention Details:
  • Drug: Farydak
    non-interventional study


Primary Outcome Measures :
  1. Response to treatment [ Time Frame: 24 months ]
    Looking for patient reproted response to treatment with panobinostat



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 be any adult who is clinically diagnosed with multiple myeloma who is actively taking panobinostat.
Criteria

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)

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): NCT04150289


Contacts
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Contact: Lauren Travis 803-329-7772 ltravis@ccorn.net
Contact: Debra Litwak 8054797793 dlitwak@securabio.com

Locations
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United States, Indiana
American Health Network Indiana Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Kisha Horan    317-462-1826    kisha_horan@ahni.com   
United States, Nevada
Southern Nevada Cancer Research Foundation and Optum Cancer Care Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Valerie Littlefield    702-384-0013    v.littlefield@sncrf.org   
Principal Investigator: Khawaja Jahangir, MD         
United States, North Carolina
Oncology Specialists of Charlotte Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Joe Howe    704-342-1900    joe.howe@djlresearch.com   
Principal Investigator: Justin Favaro, MD         
Southern Oncology Specialists Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Lisa Roberts    704-659-7833      
Principal Investigator: William Mitchell, MD         
United States, Pennsylvania
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Terry Burke    717-334-4033    terry@gettysburgoncology.com   
Principal Investigator: Satish Shah, MD         
United States, South Carolina
Coastal Cancer Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Denise Paretti       clindir@coastalcancercenter.com   
Carolina Blood and Cancer Care Associates Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Lauren Travis    803-329-7772    ltravis@cbcca.net   
Principal Investigator: Sashi Naidu, MD         
Sponsors and Collaborators
SecuraBio
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Responsible Party: SecuraBio
ClinicalTrials.gov Identifier: NCT04150289    
Other Study ID Numbers: 20192475
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by SecuraBio:
Farydak
panobinostat
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
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action