Connect® Myeloid Disease Registry

Inclusion Criteria:

• Patients must be able to provide written informed consent form (ICF)
• Must be willing and able to complete baseline and follow-up HRQoL instruments, forwhich patients must be proficient in either English or Spanish
• AML patients must be at least 55 years of age at the time of informed consent.
• MF, ICUS, and MDS patients must be at least 18 years of age at the time of informedconsent. Newly diagnosed Idiopathic Cytopenias of Undetermined Significance (ICUS), MyelodysplasticSyndromes (MDS), Acute Myeloid Leukemia (AML) patients:
• Newly diagnosed primary or secondary disease. To be considered "newly diagnosed", apatient's confirmed diagnosis must be made no more than 60 days prior to the date ofconsent signature. (An additional 5-day window [i.e., up to 65 days prior to the dateof ICF signature] may be allowed in special circumstance upon sponsor approval)
• Cohort assignment confirmed by central eligibility review. Cohort assignment must alsobe confirmed by the site. Myelofibrosis (MF) patients:
• Patients who initiated their first active systemic treatment for MF and/or MF-relatedcytopenias within 90 days prior to the date of consent signature. This cohort allowsthe enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferativeoverlap syndromes (MDS/MPN overlap syndrome).
• Cohort assignment is confirmed by the site. Central eligibility review is notrequired. Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients:
• Patients who have initiated first active treatment regimen containing at least onenon-ESA therapy, within 90 days prior to ICF
• Cohort assignment is confirmed by site. Central eligibility review is not required. Luspatercept treated patients:
• Patient must have been at least 18 years of age at the start of luspatercept.
• Among LR-MDS patients, patient must have initiated luspatercept on or after September 1, 2023, must be ESA-naïve and luspatercept must be the first active treatment (asmonotherapy or part of a treatment regimen) for their disease.
• Among all other myeloid malignancies, there is no date restriction for initiation ofluspatercept .Patient may have received prior treatment for their disease.
• Patient must have at least 3 months of follow-up from start of luspatercept treatmentat the participating site.

Exclusion Criteria:

• Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based onmorphology, immunophenotype, molecular assay or karyotype
• Currently enrolled in any interventional clinical trial where the patient is beingtreated with an investigational product that cannot be identified.
• Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS) patients who received or are receiving active (disease modifying) therapy forthe treatment of MDS prior to the date of informed consent.
• Acute Myeloid Leukemia (AML) patients who initiated active (disease modifyingtreatment for AML more than 2 weeks prior to the date of consent.
• Myelofibrosis (MF) and Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndromepatients with suspected juvenile myelomonocytic leukemia (JMML). Luspatercept treated patients:
• Patient must not be currently or previously enrolled in the Connect Myeloid Registry.
• Patient must not have received luspatercept as part of a clinical trial.