The purpose of the Connect® Myeloid disease registry is to provide unique insights into treatment decisions and treatment patterns as they relate to clinical outcomes of patients with myeloid diseases in routine clinical practice. This disease registry will also evaluate molecular and cellular markers that may provide further prognostic classification which may or may not be predictive of therapy and clinical outcomes.
This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including initial treatment and any subsequent therapy. Data on treatment outcomes, including response rates as measured by the treating physician, evidence of progression, survival, and patient-reported outcomes will be collected quarterly on the electronic CRF.
Study Type
OBSERVATIONAL
Enrollment
2,013
Prescribed by treating physician as per product label.
Patient Demographics- MDS/AML/ICUS Cohorts
Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, ICUS, and AML.
Time frame: Up to 8 years
Diagnostic and Treatment Patterns- MDS/AML/ICUS Cohorts
Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients with LR or HR MDS, ICUS, and AML
Time frame: Up to 8 years
Safety and Effectiveness- MDS/AML/ICUS Cohorts
Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events.
Time frame: Up to 8 years
Patient Demographics- MF Cohort
Describe demographics, baseline characteristics, patient recorded outcomes, and clinical outcomes of patients enrolled to the MF cohort
Time frame: Up to 5 years
Diagnostic and Treatment Patterns- MF Cohort
Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients enrolled in the MF Cohort
Time frame: Up to 5 years
Safety and Effectiveness- MF Cohort
Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events.
Time frame: Up to 5 years
Treatment effectiveness - LTC
Describe clinical response to treatment, transfusion information, ECOG performance status and deaths.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DCH Health System (Lewis and Faye Manderson Cancer Center)
Tuscaloosa, Alabama, United States
Arizona Oncology
Phoenix, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Local Institution - 1273
Tucson, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Clopton Clinic of Jonesboro, Inc.
Jonesboro, Arkansas, United States
NEABC- Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
Local Institution - 1161
Jonesboro, Arkansas, United States
Comprehensive Blood & Cancer Center
Bakersfield, California, United States
Alta Bates Summit Comprehensive Cancer
Berkeley, California, United States
...and 148 more locations
Time frame: Minimum of 3-months post index date
Treatment patterns and clinical outcomes - LTC Cohort
Describe the myeloid malignancy treatment patterns and clinical outcomes before and after initiating luspatercept treatment
Time frame: Minimum of 3-months post index date
Transfusion information - LTC
Describe changes in hemoglobin and transfusion independence status.
Time frame: Minimum of 3-months post index date
Treatment duration - LTC Cohort
Luspatercept treatment duration
Time frame: Minimum of 3-months post index date
Patient Reported Outcome
Summarize patient reported outcomes (including e.g., Health-Related Quality of Life (HRQOL)) and economic outcomes, and their association with patient characteristics, treatment regimens, and clinical outcomes
Time frame: Up to 8 years
Correlative Studies
Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.
Time frame: Up to 8 years
Patient demographics and clinical characteristics - LTC
Describe demographics, baseline characteristics and clinical outcomes of the patients treated with luspatercept
Time frame: Baseline
Reason for treatment discontinuation - LTC
Describe reasons for luspatercept treatment discontinuation
Time frame: Minimum of 3-months post index date