Actively Recruiting
Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan
Led by Bristol-Myers Squibb · Updated on 2025-12-04
50
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan
CONDITIONS
Official Title
Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with Low Risk Myelodysplastic Syndromes (LR MDS) who are erythropoietin stimulating agent naive and non-transfusion dependent, confirmed by bone marrow aspirate with less than 5% blasts
- Participants with unexplained anemia suspected to be related to myelodysplastic syndromes after excluding other common anemia causes
- Hemoglobin level below 10.0 g/dl in the most recent blood test or average of last two tests within 30 days prior to enrollment
- Participants aged 18 years or older at the time of consent
- Participants able and willing to provide informed consent
- Participants able to complete study requirements
- For qualitative phase: Participants with moderate or greater severity on at least one Patient Global Impression-Severity item
You will not qualify if you...
- Difficulty providing informed consent or participating due to insufficient Japanese language skills
- Difficulty answering quality of life questionnaires or responding during interviews
- Receipt of red blood cell transfusion within 16 weeks prior to enrollment, except 1-2 units for acute events or comorbidities
- Prior treatment with drugs related to anemia such as erythropoiesis stimulating agents or immunosuppressants
- Diagnosis of myelodysplastic/myeloproliferative neoplasms (MDS/MPN) per WHO 2016 classification
- Secondary MDS caused by chemical injury or prior chemotherapy/radiation treatment
- History of acute myeloid leukemia
- Major surgery within 8 weeks prior to enrollment without full recovery
- History of cerebrovascular accident, deep venous thrombosis, embolism, or thrombosis within 6 months prior to enrollment
- Any condition or medication interfering with study data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mebix. Inc
Minato-ku, Tokyo, Japan, 1050001
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
F
First line of the email MUST contain NCT # and Site #
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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