An observational study in Myelodysplastic Syndrome and Beta Thalassemia, sponsored by Bristol-Myers Squibb. Recruiting at 2 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Bristol-Myers Squibb · Observational
Among 18 studies in Myelodysplastic Syndromes by Bristol-Myers Squibb — 3 open to participants now, 7 under way, 3 of them phase 3. Myelodysplastic Syndromes · Bristol-Myers Squibb.
Among the 18 studies in Myelodysplastic Syndromes by Bristol-Myers Squibb, this one is the 9th largest by planned enrollment of the 13 observational ones, is one of 6 that started in 2024, is one of 13 observational ones, and was the 6th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 104 is below the median of 150 across 214 observational studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →3 of the 18 studies in Myelodysplastic Syndromes by Bristol-Myers Squibb are open now, in 4 countries. Each count lists the studies.
Of the 262 Myelodysplastic Syndromes studies recruiting now, 165 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 19 Years and older · all sexes.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2022; this study’s year is marked. 6 started in 2024.
Median enrollment 106 across the 5 interventional studies, 190 across the 13 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Myelodysplastic Syndromes by Bristol-Myers Squibb, from their registry updates:
The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.
Adults with transfusion-dependent anemia associated with very low, low, and intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or MDS/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who had an unsatisfactory response to, or are ineligible for erythropoietin-based therapy, and adults with transfusion-dependent anemia associated with beta thalassemia, who will begin therapy with luspatercept.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Luspatercept
According to the approved label
Number of participants with adverse events (AEs)
Time frame: Up to 6 months
Not enrolling at this site.
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Dec 2027, 44 months after the start.
Of 101 observational studies under Myelodysplastic Syndromes, half reached primary completion within 84 months of starting (the median), counting those still running; a quarter within 34. This study's planned 44 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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