Multiple MyelomaStep down wardNCT06286241
Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room
An observational study of Multiple Myeloma, run by Siriraj Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- How many people
- 344 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2024to 30 Jul 2024
- How long will I take part?
- 2 Years
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: multiple myeloma patients who received autologous stem cell transplantation
Who may be able to join
- 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.
Who cannot join
- Patients with concomitant other types of cancer
- Patients who refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
febrile neutropenia
incidence of febrile neutropenia
Measured: during admission
Infection
incidence of Infection
Measured: during admission
duration of admission
duration of admission
Measured: during admission
progression free survival
duration of survival
Measured: 2 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 start25 Mar 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
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
- Cohort
- Time perspective
- Other
- Enrolment
- 344 participants (estimated)
- Target duration
- 2 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
- NCT06286241
- Sponsor's protocol ID
- 877/2564(IRB2)
- Acronym
- Step down ward
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 15 Mar 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room
- ClinicalTrials.gov ID
- NCT06286241
- Acronym / sponsor ID
- Step down ward / 877/2564(IRB2)
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, autologous stem cell transplantation, HEPA-filtered room, non-HEPA-filtered room
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 25 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (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 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multiple myeloma patients who received autologous stem cell transplantation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with concomitant other types of cancer
- Patients who refuse to participate in the study.
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
febrile neutropenia
Time frame: during admission
incidence of febrile neutropenia
Infection
Time frame: during admission
incidence of Infection
duration of admission
Time frame: during admission
duration of admission
progression free survival
Time frame: 2 years
duration of survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided. Need a consensus from colleagues
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 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?
Results are not available in the source record.
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?
febrile neutropenia (time frame: during admission). The study lists 4 primary outcomes in all. 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 Mar 2024.