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

• Sponsor: SecuraBio (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04150289
• Collaborator: (none)
• Enrollment: 160
• Locations: 7
• Anticipated Duration (Months): 47.9
• Patients Per Site: 22.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
Multiple Myeloma	Drug: Farydak

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 160 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: A Disease Registry Encompassing the Care of Patients With Multiple Myeloma on Panobinostat (RECOMM)
• Actual Study Start Date: Nov 4, 2019
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2023

Outcome Measures

Primary Outcome Measures

1. Response to treatment [24 months]

   Looking for patient reproted response to treatment with panobinostat

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American Health Network Indiana	Indianapolis	Indiana	United States	46260
2	Southern Nevada Cancer Research Foundation and Optum Cancer Care	Las Vegas	Nevada	United States	89106
3	Oncology Specialists of Charlotte	Charlotte	North Carolina	United States	28204
4	Southern Oncology Specialists	Huntersville	North Carolina	United States	28078
5	Gettysburg Cancer Center	Gettysburg	Pennsylvania	United States	17325
6	Coastal Cancer Center	Myrtle Beach	South Carolina	United States	29572
7	Carolina Blood and Cancer Care Associates	Rock Hill	South Carolina	United States	29732

Sponsors and Collaborators

• SecuraBio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SecuraBio
• ClinicalTrials.gov Identifier: NCT04150289
• Other Study ID Numbers: 20192475
• First Posted: Nov 4, 2019
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Multiple Myeloma; Neoplasms, Plasma Cell; Panobinostat

Study Results

No Results Posted as of Mar 17, 2021