Multiple MyelomaHaploNCT06286228
Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease
An observational study of Multiple Myeloma, run by Siriraj Hospital.
Trial summary
The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are: 1-year progression free survival rate 1-year overall survival rate Graft-versus-host free relapsed free survival at 30-day… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2030
- How long will I take part?
- 5 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: hematologic patients with haploidentical hematopoietic stem cell transplantation
Who may be able to join
- Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including
- Myeloid diseases (acute myeloblastic leukemia, myelodysplastic syndrome, chronic myelocytic leukemia, classical and non-classical myeloproliferative disorders)
- Lymphoid disease (acute lymphoblastic leukemia, lymphoma)
- severe aplastic anemia
- Unable to find a matched sibling donor (MSD) or matched unrelated donor (MUD), and no alternative treatments
- Eastern Cooperative Oncology Group (ECOG) 0-2
Show all 11Show fewer
- normal AST and ALT, creatinine \<2g/dL, and left ventricular ejection fraction ≥50%
- age \>18 years
- Capable of informed consent and provision of written informed consent before any study procedures
- Capable of attending all study visits according to the study schedule
- Female subjects who is childbearing potential must have a negative result for pregnancy test
Who cannot join
- HIV infection, active hepatitis B, active hepatitis C
- active infection
- history of other malignancy except basal cell carcinoma and carcinoma of the cervix in situ
- A pregnant woman and/or refusal of contraception
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 hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:
- 1-year progression free survival rate
- 1-year overall survival rate
- Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year
- Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year
- Rate of Neutrophil and platelet engraftment
- Efficacy of donor specific antibody desensitization
- Relapsed rate
- Primary and late graft failure
- Safety and complication of haploHSCT
- Complication of viral, bacterial, and fungal infection
- Viral reactivation
- Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
- Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.
- Conditions
- Multiple Myeloma
- Keywords
- haploidentical hematopoietic stem cell transplantation (haploHSCT), registry
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
register hematologic patients with haploidentical hematopoietic stem cell transplantation
Measured: 5 years
Secondary outcomes (12)
progression free survival rate
Measured: 1 year
overall survival rate
Measured: 1 year
Chronic Graft-versus-host free relapsed free survival
Measured: at 180-day and 1-year
Relapsed rate
Measured: 5 years
Primary and late graft failure
Measured: 5 years
Rate of Neutrophil and platelet engraftment
Measured: during admission
Efficacy of donor specific antibody desensitization
Measured: during admission
Safety and complication of haploHSCT
Measured: 5 years
Complication of viral, bacterial, and fungal infection
Measured: during admission
Viral reactivation
Measured: during admission
outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
Measured: 5 years
cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
Measured: 5 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 2029 (estimated)
- Study completion1 Apr 2030 (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
- Prospective
- Enrolment
- 43 participants (estimated)
- Target duration
- 5 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
- NCT06286228
- Sponsor's protocol ID
- 751/2563(IRB4)
- Acronym
- Haplo
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 1 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease
- ClinicalTrials.gov ID
- NCT06286228
- Acronym / sponsor ID
- Haplo / 751/2563(IRB4)
- Conditions
- Multiple Myeloma
- Keywords
- haploidentical hematopoietic stem cell transplantation (haploHSCT), registry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2030 (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 hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:
- 1-year progression free survival rate
- 1-year overall survival rate
- Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year
- Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year
- Rate of Neutrophil and platelet engraftment
- Efficacy of donor specific antibody desensitization
- Relapsed rate
- Primary and late graft failure
- Safety and complication of haploHSCT
- Complication of viral, bacterial, and fungal infection
- Viral reactivation
- Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
- Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT 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
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hematologic patients with haploidentical hematopoietic stem cell transplantation
Key inclusion criteria (11 listed)
- Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including
- Unable to find a matched sibling donor (MSD) or matched unrelated donor (MUD), and no alternative treatments
- Eastern Cooperative Oncology Group (ECOG) 0-2
- normal AST and ALT, creatinine \<2g/dL, and left ventricular ejection fraction ≥50%
- age \>18 years
Key exclusion criteria (4 listed)
- HIV infection, active hepatitis B, active hepatitis C
- active infection
- history of other malignancy except basal cell carcinoma and carcinoma of the cervix in situ
- A pregnant woman and/or refusal of contraception
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 hematologic patients with haploidentical hematopoietic stem cell transplantation
Time frame: 5 years
12 secondary outcomes
progression free survival rate
Time frame: 1 year
overall survival rate
Time frame: 1 year
Chronic Graft-versus-host free relapsed free survival
Time frame: at 180-day and 1-year
Relapsed rate
Time frame: 5 years
Primary and late graft failure
Time frame: 5 years
Rate of Neutrophil and platelet engraftment
Time frame: during admission
Efficacy of donor specific antibody desensitization
Time frame: during admission
Safety and complication of haploHSCT
Time frame: 5 years
Complication of viral, bacterial, and fungal infection
Time frame: during admission
Viral reactivation
Time frame: during admission
outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
Time frame: 5 years
cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
Time frame: 5 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 1 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.
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 11 inclusion and 4 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 1 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?
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 hematologic patients with haploidentical hematopoietic stem cell transplantation (time frame: 5 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 1 Mar 2024.