A Study to Evaluate Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Patients With Lower-Risk Myelodysplastic Syndromes Treated With Luspatercept
- Registration Number
- NCT07075406
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
-
Confirmed diagnosis of primary myelodysplastic syndromes (MDS) with lower-risk status as measured by the International Prognostic Scoring System (IPSS) or the Revised International Prognostic Scoring System (IPSS-R) at the time of diagnosis
- IPSS risk level: low, intermediate-1 (level-1 risk)
- IPSS-R risk level: very low, low, intermediate
-
Initiated luspatercept for treatment of Lower-Risk (LR)-MDS after the initial availability in each country of interest
- US: after April 2020
- Germany: after June 2020
- Spain: after June 2020
- France: after June 202
- Canada: after February 2021
-
The participant has a potential follow-up of at least 6 months from the index date (except death)
-
The participant is aged 18 years or older at the index date
-
The participant has a complete medical record or history for at least 12 months before the index date (or up to the date of initial LR-MDS diagnosis if duration between initial diagnosis and index date is less than 12 months)
- Received luspatercept as part of a clinical trial
- The participant has evidence of other malignant neoplasms prior to diagnosis of MDS, except disease free for ≥ 5 years at time of MDS diagnosis, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (stage T1a or T1b)
- The participant has a history of Acute Myeloid Leukemia prior to MDS diagnosis
- The participant has participated in clinical trials for specific treatments related to treatment of MDS
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants receiving luspatercept treatment Luspatercept -
- Primary Outcome Measures
Name Time Method Participant baseline demographics Baseline Participant baseline clinical characteristics Baseline Participant treatment history Baseline
- Secondary Outcome Measures
Name Time Method Number of participants receiving myelodysplastic syndromes (MDS) -directed treatment modalities Up to 12 months MDS-directed treatment modalities include:
* Therapies for treatment of anemia include
* Erythropoietin-stimulating agents (ESAs)
* Granulocyte-colony stimulating factors (G-CSFs
* Immunosuppressant/Immunomodulatory agents
* Hypomethylating agents
* Erythroid maturation agent
* Other MDS-directed therapies
* Other supportive care therapies
* Antibiotic therapy
* Iron chelation therapy
* Nutritional supportSystemic therapy agent or combination of agents received by participants Up to 12 months Treating clinicians' rationale for prescribing treatment(s) Up to 12 months Time to treatment discontinuation Up to 12 months Duration of treatment Up to 12 months Reason(s) for treatment discontinuation Up to 12 months Treatment dosing characteristics Up to 12 months Dosage characteristics includes:
* Daily dose at treatment initiation
* Dosing frequency
* Dose modifications
* Reason(s) for dose modification
* Dose and dosing frequency at treatment discontinuationSequence of treatments prescribed to participants Up to 12 months Number and proportion of participants who received stem-cell transplant Up to 12 months
Trial Locations
- Locations (1)
RTI Health Solutions
🇺🇸Research Triangle Park, North Carolina, United States
RTI Health Solutions🇺🇸Research Triangle Park, North Carolina, United States