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

March 12, 2024 updated by: Chutima Kunacheewa, Siriraj Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

multiple myeloma patients who received autologous stem cell transplantation

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
febrile neutropenia
Time Frame: during admission
incidence of febrile neutropenia
during admission
Infection
Time Frame: during admission
incidence of Infection
during admission
duration of admission
Time Frame: during admission
duration of admission
during admission
progression free survival
Time Frame: 2 years
duration of survival
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Collaborators

Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 877/2564(IRB2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Need a consensus from colleagues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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