Connect® Myeloid Disease Registry

Myelodysplastic Syndromes Clinical Trial

Official title:

Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01688011
• Other study ID #: AZA-MDS-006
• Secondary ID: Connect® MDS/AML
• Status: Recruiting
• Start date: December 12, 2013
• Est. completion date: March 31, 2031

Study information

• Verified date: April 2024
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: March 31, 2031
• Est. primary completion date: March 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, for which 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 informed consent.

Newly diagnosed Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML) patients:

• Newly diagnosed primary or secondary disease. To be considered "newly diagnosed", a patient's confirmed diagnosis must be made no more than 60 days prior to the date of consent signature. (An additional 5-day window [i.e., up to 65 days prior to the date of ICF signature] may be allowed in special circumstance upon sponsor approval)

• Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site.

Myelofibrosis (MF) patients:

• Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 90 days prior to the date of consent signature. This cohort allows the enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferative overlap syndromes (MDS/MPN overlap syndrome).

• Cohort assignment is confirmed by the site. Central eligibility review is not required.

Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients:

• Patients who have initiated first active treatment regimen containing at least one non-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 (as monotherapy or part of a treatment regimen) for their disease.

• Among all other myeloid malignancies, there is no date restriction for initiation of luspatercept .Patient may have received prior treatment for their disease.

• Patient must have at least 3 months of follow-up from start of luspatercept treatment at the participating site.

Exclusion Criteria:

• Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype

• Currently enrolled in any interventional clinical trial where the patient is being treated 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 for the treatment of MDS prior to the date of informed consent.

• Acute Myeloid Leukemia (AML) patients who initiated active (disease modifying treatment for AML more than 2 weeks prior to the date of consent.

• Myelofibrosis (MF) and Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndrome patients 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Primary Myelofibrosis
• Syndrome

Intervention

Drug:
• Luspatercept
Prescribed by treating physician as per product label.

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico Hematology Oncology Group	Bayamon
Puerto Rico	Fundacion de lnvestigaci6n	San Juan
Puerto Rico	VA Caribbean Healthcare System CRADA	San Juan
United States	Hendrick Cancer Center	Abilene	Texas
United States	Summa Health System	Akron	Ohio
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	BSL Health System (Harrington Cancer Center)	Amarillo	Texas
United States	Texas Oncology, Amarillo Cancer Center	Amarillo	Texas
United States	McFarland Clinic, P.C	Ames	Iowa
United States	St. Vincent Anderson Regional Hospital Research	Anderson	Indiana
United States	University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce	Ann Arbor	Michigan
United States	Ashland-Bellefonte Cancer Center	Ashland	Kentucky
United States	Emory University	Atlanta	Georgia
United States	Piedmont Cancer Institute, P.C. (was Peachtree Hematology-Oncology Consultants)	Atlanta	Georgia
United States	Georgia Regents University Cancer Center	Augusta	Georgia
United States	Togus Va Medical Center	Augusta	Minnesota
United States	Comprehensive Blood & Cancer Center	Bakersfield	California
United States	Weinberg Cancer Institute at Franklin Square	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center (Baton Rouge)	Baton Rouge	Louisiana
United States	Our Lady of the Lake Physician Group-Medical Oncology	Baton Rouge	Louisiana
United States	PeaceHealth St Joseph Cancer Center	Bellingham	Washington
United States	Alta Bates Summit Comprehensive Cancer	Berkeley	California
United States	Sutter East Bay Hospitals (dba Jordan Research and Education Institute - REDI)	Berkeley	California
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Billings Clinic	Billings	Montana
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	IU health Bloomington Hospital	Bloomington	Indiana
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	MCDA - Central Care Center	Bolivar	Missouri
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University Cancer Institute	Boynton Beach	Florida
United States	Albert Einstein College of Medicine - Montefiore Medical Center	Bronx	New York
United States	New York Cancer and Blood Specialists	Bronx	New York
United States	Maimonides Cancer Center	Brooklyn	New York
United States	Southeast Georgia Health System	Brunswick	Georgia
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Southeast Cancer Center	Cape Girardeau	Missouri
United States	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina
United States	Memorial Hospital of Laramie County dba Cheyenne Regional Medical Center	Cheyenne	Wyoming
United States	Hektoen Inst for Medical Resrch on behalf of itself and John H Stroger Hosp	Chicago	Illinois
United States	RUSH University Cancer Center	Chicago	Illinois
United States	Delaware Clinical and Laboratory Physicians	Christiana	Delaware
United States	TriHealth, Good Samaritan Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Local Institution - 1088	Cleveland	Ohio
United States	University Hospitals, Case Medical Center	Cleveland	Ohio
United States	Boone Hospital Center	Columbia	Michigan
United States	Harry S Truman Memorial Veterans' Hospital	Columbia	Missouri
United States	Maryland Oncology Hematology	Columbia	Maryland
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center	Columbus	Ohio
United States	John Muir Clinical Research Center	Concord	California
United States	Bassett Heathcare Network	Cooperstown	New York
United States	Christus Spohn Cancer Center	Corpus Christi	Texas
United States	Coastal Bend Cancer Center	Corpus Christi	Texas
United States	Good Samaritan Hospital Corvallis	Corvallis	Oregon
United States	Mary Bird Perkins Cancer Center at St. Tammany	Covington	Louisiana
United States	QCCA - Pontchartrain Cancer Center	Covington	Louisiana
United States	Western Maryland Health System	Cumberland	Maryland
United States	Dallas VA Medical Center	Dallas	Texas
United States	HOLD - Texas Oncology, Dallas	Dallas	Texas
United States	Texas Oncology - Sammons Cancer Center	Dallas	Texas
United States	Halifax Health Center for Oncology	Daytona Beach	Florida
United States	Oakwood Healthcare Inc.	Dearborn	Michigan
United States	Saint Joseph Hospital, Cancer Centers of Colorado	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	John D. Dingell VA Medical Center /Cynthia Marbury	Detroit	Michigan
United States	Consultants in Medical Oncology and Hematology	Drexel Hill	Pennsylvania
United States	Essentia Health Oncology Clinical Trials	Duluth	Minnesota
United States	Hematology and Oncology Assoc of NEPA	Dunmore	Pennsylvania
United States	Hematology Oncology Associates of Central NY	East Syracuse	New York
United States	Southdale Cancer Clinic	Edina	Minnesota
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	NorthShore University Health System	Evanston	Illinois
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	Detroit Clinical Research Center	Farmington Hills	Michigan
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	Broward Oncology Associates	Fort Lauderdale	Florida
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Southeast FL Hematology Oncology Grp	Fort Lauderdale	Florida
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas
United States	Robert A. Moss, M.D.,F AC.P, Inc	Fountain Valley	California
United States	VA Central California Health Care System	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	UTMB Galveston	Galveston	Texas
United States	Central Care Cancer Center	Garden City	Kansas
United States	C.R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Bellin Memorial Hospital/ Bellin Cancer Team	Green Bay	Wisconsin
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Marin Cancer Care	Greenbrae	California
United States	Leo W Jenkins Cancer Center	Greenville	North Carolina
United States	Prisma Health Cancer Institute - Upstate	Greenville	South Carolina
United States	Ascension St. John Hospital_Hematology (was St. Johns Hospital and Hematology-Oncology Associates East PC )	Grosse Pointe Woods	Michigan
United States	John Theurer Cancer Center (Hackensack U Med Center)	Hackensack	New Jersey
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Hattiesburg Clinic Hematology/Oncology	Hattiesburg	Mississippi
United States	DuPage Medical Group - Oncology (University of Rodchester)	Hinsdale	Illinois
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Huntington Medical Group	Huntington Station	New York
United States	ONCOLOGY SPECIALTIES, PC - Clearview Cancer Institute	Huntsville	Alabama
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	University of Florida College of Medicine	Jacksonville	Florida
United States	Columbia Comprehensive Cancer Care Clinic	Jefferson City	Missouri
United States	Local Institution - 1047	Johnson City	New York
United States	Joliet Oncology Hematology Associates Ltd	Joliet	Illinois
United States	Local Institution - 1145	Joliet	Illinois
United States	Clopton Clinic of Jonesboro, Inc.	Jonesboro	Arkansas
United States	Local Institution - 1161	Jonesboro	Arkansas
United States	NEABC- Fowler Family Center for Cancer Care	Jonesboro	Arkansas
United States	Mercy Cancer Center - Joplin	Joplin	Missouri
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Kadlec Regional Medical Center (KRMC)	Kennewick	Washington
United States	Dayton Physicians	Kettering	Ohio
United States	Kinston Medical Specialists	Kinston	North Carolina
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	University of Tennessee Medical Center Cancer Intitute	Knoxville	Tennessee
United States	Gundersen Lutheran Inc	La Crosse	Wisconsin
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Horizon Oncology Research, Inc	Lafayette	Indiana
United States	Watson Clinic Center for Cancer Care and Research	Lakeland	Florida
United States	Lancaster Cancer Center	Lancaster	Pennsylvania
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Michigan State University/Breslin Cancer Center	Lansing	Michigan
United States	Oncology and Hematology of South Texas, PA	Laredo	Texas
United States	Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Cancer and Blood Disease Center	Lecanto	Florida
United States	Maine Research Associates/Central Maine Medicine	Lewiston	Maine
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	CARTI	Little Rock	Arkansas
United States	Baptist Health Systems, Inc., DBA Baptist	Louisville	Kentucky
United States	Southwest Cancer Treatment & Research Center	Lubbock	Texas
United States	Lynchburg Hematology Oncology Clinic	Lynchburg	Virginia
United States	Regional Cancer Care Associates	Manchester	Connecticut
United States	VA Medical Center Manchester	Manchester	New Hampshire
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Texas Oncology, McAllen (plus 2 satelite sites)	McAllen	Texas
United States	Regional One Health	Memphis	Tennessee
United States	Texas Oncology, Midland	Midland	Texas
United States	Columbia St. Mary'S	Milwaukee	Wisconsin
United States	Froedtert & Medical College of Wisconsin CLCC	Milwaukee	Wisconsin
United States	Montana Cancer Institute Foundation	Missoula	Montana
United States	Pacific Cancer Care	Monterey	California
United States	West Virginia University	Morgantown	West Virginia
United States	Hematology-Oncology Associates of Northern New Jersey	Morristown	New Jersey
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Floyd Memorial Cancer Center of Indiana	New Albany	Indiana
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Weill Cornell Medical College	New York	New York
United States	Oncology Hematology Associates of Southwest Indiana	Newburgh	Indiana
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Oncology Specialists, SC	Niles	Illinois
United States	Ocala Oncology	Ocala	Florida
United States	Community Cancer Trials of Utah	Ogden	Utah
United States	INTEGRIS Cancer Institute of Oklahoma Proton Campus	Oklahoma City	Oklahoma
United States	INTEGRIS Cancer Institute Southwest Medical Center	Oklahoma City	Oklahoma
United States	Vista Oncology Inc. PS	Olympia	Washington
United States	21st Century Oncology	Orange Park	Florida
United States	Adventist Health System/Sunbelt, Inc.	Orlando	Florida
United States	St Joseph Healthcare System	Paterson	New Jersey
United States	Memorial Healthcare System	Pembroke Pines	Florida
United States	Sacred Heart Medical Oncology Group	Pensacola	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	Arizona Oncology	Phoenix	Arizona
United States	Allegheny Singer Research Institute (was West Penn Hospital)	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	HealthCare Alliance (UHA)	Pleasanton	California
United States	Local Institution - 1131	Portland	Oregon
United States	Providence Cancer Center	Portland	Oregon
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	Quincy Medical Group	Quincy	Illinois
United States	Wheaton Franciscan Cancer Care - All Saints	Racine	Wisconsin
United States	Renown Regional Medical Center	Reno	Nevada
United States	Rochester General Hospital	Rochester	New York
United States	University of Rochester ~ Wilmot Cancer Institute	Rochester	New York
United States	Cancer Care Centers of Brevard	Rockledge	Florida
United States	St. Francis Hospital	Roslyn	New York
United States	Scott & White Healthcare	Round Rock	Texas
United States	Foley Cancer Center/RRMC	Rutland	Vermont
United States	Mercy Cancer Center	Sacramento	California
United States	Heartland Regional Medical Center (Heartland Health)	Saint Joseph	Missouri
United States	Local Institution - 1110	Saint Louis	Missouri
United States	Mercy Cancer - St. Louis	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Metro MN CCOP/Park Nicollet Institute	Saint Louis Park	Minnesota
United States	Metro MN CCOP/Park Nicollet Institute	Saint Louis Park	Minnesota
United States	Salem Health	Salem	Oregon
United States	Local Institution - 1016	San Diego	California
United States	Local Institution - 1027	Santa Rosa	California
United States	St Joseph Heritage Healthcare	Santa Rosa	California
United States	Benaroya Research Institute at Virginia Mason	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	Edward H. KaPlan MD & Associates	Skokie	Illinois
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Somerset Medical Center 110 Rehill Avenue	Somerville	New Jersey
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	St. John Providence Hospital System	Southfield	Michigan
United States	Sparta Cancer Center	Sparta	New Jersey
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Mercy Research - Springfield	Springfield	Missouri
United States	Simmons Cancer Institute at Southern Illinois University	Springfield	Illinois
United States	Bennett Cancer Center Stamford Hospital	Stamford	Connecticut
United States	St. Joseph's Regional Cancer Center	Stockton	California
United States	Tallahassee Memorial Cancer Center	Tallahassee	Florida
United States	Baylor Research Institute dba Scott & White Memorial Hospital	Temple	Texas
United States	Ashwin Kashyap MD, INC.	Thousand Oaks	California
United States	Space Coast Medical Associates	Titusville	Florida
United States	University of Toledo Medical Center (Utmc)	Toledo	Ohio
United States	Cotton O'Neil Clinical Research/ Stormont Vail Health	Topeka	Kansas
United States	UM St. Joseph's Medical Center	Towson	Maryland
United States	Local Institution - 1273	Tucson	Arizona
United States	The University of Arizona Cancer Center	Tucson	Arizona
United States	Oklahoma Cancer Specialist and Research Institute	Tulsa	Oklahoma
United States	DCH Health System (Lewis and Faye Manderson Cancer Center)	Tuscaloosa	Alabama
United States	Blood and cancer Center of East Texas	Tyler	Texas
United States	Carle Cancer Center	Urbana	Illinois
United States	New York Medical College	Valhalla	New York
United States	Indian River Memorial Hospital Scully Welsh Cancer Center	Vero Beach	Florida
United States	Good Samaritan Hospital - Wabash Valley Clinical Research Center	Vincennes	Indiana
United States	Providence St. Mary Regional Cancer Center	Walla Walla	Washington
United States	MedStar Health Research Institute (Washington)	Washington	District of Columbia
United States	Covenant Clinic	Waterloo	Iowa
United States	Prairie Lakes Health Systen, Inc	Watertown	South Dakota
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	Reading Hospital - McGlinn Cancer Institute	West Reading	Pennsylvania
United States	Carroll Regional Cancer Center	Westminster	Maryland
United States	VA Medical Center - White River Junction	White River Junction	Vermont
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Ccs Oncology	Williamsville	New York
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Bond Clinic	Winter Haven	Florida
United States	Cancer Care Associates of York	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Steensma DP, Abedi M, Bejar R, Cogle CR, Foucar K, Garcia-Manero G, George TI, Grinblatt D, Komrokji R, Ma X, Maciejewski J, Pollyea DA, Savona MR, Scott B, Sekeres MA, Thompson MA, Swern AS, Nifenecker M, Sugrue MM, Erba H. Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study. BMC Cancer. 2016 Aug 19;16:652. doi: 10.1186/s12885-016-2710-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Demographics- MDS/AML/ICUS Cohorts	Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, ICUS, and AML.	Up to 8 years
Primary	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	Up to 8 years
Primary	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.	Up to 8 years
Primary	Patient Demographics- MF Cohort	Describe demographics, baseline characteristics, patient recorded outcomes, and clinical outcomes of patients enrolled to the MF cohort	Up to 5 years
Primary	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	Up to 5 years
Primary	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.	Up to 5 years
Primary	Treatment effectiveness - LTC	Describe clinical response to treatment, transfusion information, ECOG performance status and deaths.	Minimum of 3-months post index date
Primary	Treatment patterns and clinical outcomes - LTC Cohort	Describe the myeloid malignancy treatment patterns and clinical outcomes before and after initiating luspatercept treatment	Minimum of 3-months post index date
Primary	Transfusion information - LTC	Describe changes in hemoglobin and transfusion independence status.	Minimum of 3-months post index date
Primary	Treatment duration - LTC Cohort	Luspatercept treatment duration	Minimum of 3-months post index date
Secondary	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	Up to 8 years
Secondary	Correlative Studies	Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.	Up to 8 years
Secondary	Patient demographics and clinical characteristics - LTC	Describe demographics, baseline characteristics and clinical outcomes of the patients treated with luspatercept	Baseline
Secondary	Reason for treatment discontinuation - LTC	Describe reasons for luspatercept treatment discontinuation	Minimum of 3-months post index date