Myelodysplastic Syndromes
Conditions
Keywords
Lower-risk myelodysplastic syndromes (LR-MDS)
Brief summary
The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes
Interventions
DRUGLuspatercept
According to product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant baseline demographics | Baseline |
| Participant baseline clinical characteristics | Baseline |
| Participant treatment history | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment discontinuation | Up to 12 months | — |
| Duration of treatment | Up to 12 months | — |
| Reason(s) for treatment discontinuation | Up to 12 months | — |
| 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 support |
| Sequence of treatments prescribed to participants | Up to 12 months | — |
| Number and proportion of participants who received stem-cell transplant | 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 discontinuation |
| Systemic therapy agent or combination of agents received by participants | Up to 12 months | — |
| Treating clinicians' rationale for prescribing treatment(s) | Up to 12 months | — |
Countries
United States
Outcome results
None listed