Multiple MyelomaRECOMMNCT04150289
A Disease Registry Encompassing the Care Of Patients With Multiple Myeloma on Panobinostat
An observational study of Multiple Myeloma, run by pharmaand GmbH at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Farydak
- How many people
- 248 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Nov 2019to 30 Mar 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be any adult who is clinically diagnosed with multiple myeloma who is actively taking panobinostat.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28204
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Southern Oncology Specialists
Huntersville, North Carolina, 28078
American Health Network Indiana
Indianapolis, Indiana, 46260
Southern Nevada Cancer Research Foundation and Optum Cancer Care
Las Vegas, Nevada, 89106
Coastal Cancer Center
Myrtle Beach, South Carolina, 29572
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Farydak
- Keywords
- Farydak, panobinostat
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FarydakDrug
non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Looking for patient reproted response to treatment with panobinostat
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start4 Nov 2019
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- pharmaand GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150289
- Sponsor's protocol ID
- 20192475
- Acronym
- RECOMM
- Status last verified
- Jun 2023
- First submitted
- 31 Oct 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Disease Registry Encompassing the Care of Patients With Multiple Myeloma on Panobinostat (RECOMM)
- ClinicalTrials.gov ID
- NCT04150289
- Acronym / sponsor ID
- RECOMM / 20192475
- Conditions
- Multiple Myeloma
- Keywords
- Farydak, panobinostat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- pharmaand GmbHIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be any adult who is clinically diagnosed with multiple myeloma who is actively taking panobinostat.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Farydaknon-interventional study | Drug | – |
Primary outcome
Response to treatment
Time frame: 24 months
Looking for patient reproted response to treatment with panobinostat
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by pharmaand GmbH at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.