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NCT Number: NCT06286215

Registry of Patients With Plasma Cell Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • insufficient data needed for analysis

Treatment and study plan

Primary outcomes

  1. register the plasma cell disorder patients

    Time frame: 10 years

    register the plasma cell disorder patients

Secondary outcomes

  1. incidence of plasma cell disorders

    Time frame: 10 years

    incidence of plasma cell disorders both before and after malignancy

  2. Time to progression

    Time frame: 10 years

    • Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
  3. Progression free survival

    Time frame: 10 years

    Progression free survival

  4. overall survival

    Time frame: 10 years

    overall survival

  5. influencing factors

    Time frame: 10 years

    factors influencing overall survival, progression-free survival, and time to progression

  6. Symptoms and signs

    Time frame: 10 years

    Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients

  7. genetic characteristics

    Time frame: 10 years

    genetic characteristics of plasma cell disorder

  8. cost-effectiveness

    Time frame: 10 years

    cost-effectiveness of treatment in Thailand

Study contacts

Contact information is provided by the study sponsor or research team.

Chutima Kunacheewa, MD

CONTACT

[email protected]

66896790959

Weerapat Owatthanapanich, MD

CONTACT

[email protected]

66891081983

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Acronym: Registry PCD

Important dates

Study start
2024
Primary completion
2034
Study completion
2035
First posted
Feb 29, 2024
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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