Plasma Cell DisordersRegistry PCDNCT06286215
Registry of Patients With Plasma Cell Disorders
An observational study of Plasma Cell Disorders, run by Siriraj Hospital.
Trial summary
The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are: The incidence of plasma cell disorders both before and after malignancy Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Disorders
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: plasma cell disorder patients
Who may be able to join
- Both existing and newly diagnosed patients with plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS, light chain amyloidosis, solitary plasmacytoma, and multiple myeloma, according to the diagnostic criteria of the International Myeloma Working Group 2014
- Aged 18 years and above
Who cannot join
- insufficient data needed for analysis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:
- The incidence of plasma cell disorders both before and after malignancy
- Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
- Progression free survival (PFS)
- overall survival
- factors influencing overall survival, progression-free survival, and time to progression
- Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
- genetic characteristics of plasma cell disorder
- cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.
- Conditions
- Plasma Cell Disorders
- Keywords
- registry, plasma cell disorder
- Medical subject headings
- Neoplasms, Plasma Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
register the plasma cell disorder patients
register the plasma cell disorder patients
Measured: 10 years
Secondary outcomes (8)
incidence of plasma cell disorders
incidence of plasma cell disorders both before and after malignancy
Measured: 10 years
Time to progression
- Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
Measured: 10 years
Progression free survival
Progression free survival
Measured: 10 years
overall survival
overall survival
Measured: 10 years
influencing factors
factors influencing overall survival, progression-free survival, and time to progression
Measured: 10 years
Symptoms and signs
Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients
Measured: 10 years
genetic characteristics
genetic characteristics of plasma cell disorder
Measured: 10 years
cost-effectiveness
cost-effectiveness of treatment in Thailand
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2034 (estimated)
- Study completion1 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chutima Kunacheewa, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286215
- Sponsor's protocol ID
- 586/2564(IRB2)
- Acronym
- Registry PCD
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need a consensus from colleagues
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients With Plasma Cell Disorders
- ClinicalTrials.gov ID
- NCT06286215
- Acronym / sponsor ID
- Registry PCD / 586/2564(IRB2)
- Conditions
- Plasma Cell Disorders
- Keywords
- registry, plasma cell disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2034 (estimated)
- Study completion
- 1 Apr 2035 (estimated)
- First posted
- 29 Feb 2024 (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.
The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:
- The incidence of plasma cell disorders both before and after malignancy
- Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
- Progression free survival (PFS)
- overall survival
- factors influencing overall survival, progression-free survival, and time to progression
- Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
- genetic characteristics of plasma cell disorder
- cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- plasma cell disorder patients
Key inclusion criteria (2 listed)
- Both existing and newly diagnosed patients with plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS, light chain amyloidosis, solitary plasmacytoma, and multiple myeloma, according to the diagnostic criteria of the International Myeloma Working Group 2014
- Aged 18 years and above
Key exclusion criteria (1 listed)
- insufficient data needed for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
register the plasma cell disorder patients
Time frame: 10 years
register the plasma cell disorder patients
8 secondary outcomes
incidence of plasma cell disorders
Time frame: 10 years
Time to progression
Time frame: 10 years
Progression free survival
Time frame: 10 years
overall survival
Time frame: 10 years
influencing factors
Time frame: 10 years
Symptoms and signs
Time frame: 10 years
genetic characteristics
Time frame: 10 years
cost-effectiveness
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Undecided. Need a consensus from colleagues
Related trials for Plasma Cell Disorders
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RecruitingPhase 2
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Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Cell Disorders, run by Siriraj Hospital.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chutima Kunacheewa, MD (66896790959, chutima.kua@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
register the plasma cell disorder patients (time frame: 10 years). 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 29 Feb 2024.