NCT04150289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

2.4 years

First QC Date

October 31, 2019

Last Update Submit

June 12, 2023

Conditions

Keywords

Farydakpanobinostat

Outcome Measures

Primary Outcomes (1)

  • Response to treatment

    Looking for patient reproted response to treatment with panobinostat

    24 months

Interventions

non-interventional study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

American Health Network Indiana

Indianapolis, Indiana, 46260, United States

Location

Southern Nevada Cancer Research Foundation and Optum Cancer Care

Las Vegas, Nevada, 89106, United States

Location

Oncology Specialists of Charlotte

Charlotte, North Carolina, 28204, United States

Location

Southern Oncology Specialists

Huntersville, North Carolina, 28078, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Coastal Cancer Center

Myrtle Beach, South Carolina, 29572, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

November 4, 2019

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations