Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room

NCT06286241 | Not Yet Recruiting

• 1 other identifier: 877/2564(IRB2)
• Study Type: observational
• Target: 344
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in HEPA-filtered room and non-HEPA-filtered room. The main questions it aims to answer are:

• The incidence of febrile neutropenia, infection, and duration of hospital stay
• 2-year progression free survival Participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; autologous stem cell transplantation; HEPA-filtered room; non-HEPA-filtered room

Outcome Measures

Primary Outcomes (4)

• febrile neutropenia

  incidence of febrile neutropenia

  during admission

• Infection

  incidence of Infection

  during admission

• duration of admission

  duration of admission

  during admission

• progression free survival

  duration of survival

  2 years

Study Arms (2)

HEPA-filtered room

multiple myeloma patients who received autologous stem cell transplantation were admitted in HEPA-filtered room

non-HEPA-filtered room

multiple myeloma patients who received autologous stem cell transplantation were admitted in non-HEPA-filtered room

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

multiple myeloma patients who received autologous stem cell transplantation

You may qualify if:

• aged 18 - 65 years old
• Patients with multiple myeloma undergoing treatment with autologous stem cell transplantation and having a Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score less than or equal to 2
• Patients must provide signed consent to participate in the research if they undergo ASCT after the study has been approved.
• If patients undergo ASCT before the study approval, retrospective data will be collected.

You may not qualify if:

• Patients with concomitant other types of cancer
• Patients who refuse to participate in the study.

Sponsors & Collaborators

• Siriraj Hospital: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chutima Kunacheewa, MD

CONTACT

+66896790959; chutima.kua@mahidol.ac.th

Weerapat Owattanapanich, MD

CONTACT

+66891081983; weerapat.owa@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: March 25, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03