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Connect® Myeloid Disease Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01688011
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Primary Myelofibrosis Myelodysplastic Syndromes Leukemia, Myeloid, Acute Drug: Luspatercept

Detailed 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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2300 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 8 Years
Official Title: Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Actual Study Start Date : December 12, 2013
Estimated Primary Completion Date : March 31, 2031
Estimated Study Completion Date : March 31, 2031

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Newly diagnosed Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Newly diagnosed lower risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Newly diagnosed Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Newly diagnosed higher risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Newly diagnosed Acute Myeloid Leukemia (AML)
Newly diagnosed AML patients (≥55 years old, excluding patients with acute promyelocytic leukemia (APL).
Treated Myelofibrosis (MF)
Newly treated MF patients receiving treatment for MF or MF-related cytopenias. This cohort also includes patients with myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) overlap syndromes, excluding juvenile myelomonocytic leukemia (JMML).
Newly diagnosed Idiopathic cytopenia of undetermined significance (ICUS)
Newly diagnosed ICUS patients.
Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Treated LR-MDS patients receiving first active treatment regimen containing at least one non-ESA therapy
Luspatercept treated cohort (LTC)
Participants that have initiated luspatercept treatment for a myeloid malignancy.
 Drug: Luspatercept
Prescribed by treating physician as per product label.


Outcome Measures
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Primary Outcome Measures :
  1. Patient Demographics- MDS/AML/ICUS Cohorts [ Time Frame: Up to 8 years ]
    Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, ICUS, and AML.

  2. Diagnostic and Treatment Patterns- MDS/AML/ICUS Cohorts [ Time Frame: Up to 8 years ]
    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

  3. Safety and Effectiveness- MDS/AML/ICUS Cohorts [ Time Frame: Up to 8 years ]
    Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events.

  4. Patient Demographics- MF Cohort [ Time Frame: Up to 5 years ]
    Describe demographics, baseline characteristics, patient recorded outcomes, and clinical outcomes of patients enrolled to the MF cohort

  5. Diagnostic and Treatment Patterns- MF Cohort [ Time Frame: Up to 5 years ]
    Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients enrolled in the MF Cohort

  6. Safety and Effectiveness- MF Cohort [ Time Frame: Up to 5 years ]
    Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events.

  7. Treatment effectiveness - LTC [ Time Frame: Minimum of 3-months post index date ]
    Describe clinical response to treatment, transfusion information, ECOG performance status and deaths.

  8. Treatment patterns and clinical outcomes - LTC Cohort [ Time Frame: Minimum of 3-months post index date ]
    Describe the myeloid malignancy treatment patterns and clinical outcomes before and after initiating luspatercept treatment

  9. Transfusion information - LTC [ Time Frame: Minimum of 3-months post index date ]
    Describe changes in hemoglobin and transfusion independence status.

  10. Treatment duration - LTC Cohort [ Time Frame: Minimum of 3-months post index date ]
    Luspatercept treatment duration


Secondary Outcome Measures :
  1. Patient Reported Outcome [ Time Frame: Up to 8 years ]
    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

  2. Correlative Studies [ Time Frame: Up to 8 years ]
    Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.

  3. Patient demographics and clinical characteristics - LTC [ Time Frame: Baseline ]
    Describe demographics, baseline characteristics and clinical outcomes of the patients treated with luspatercept

  4. Reason for treatment discontinuation - LTC [ Time Frame: Minimum of 3-months post index date ]
    Describe reasons for luspatercept treatment discontinuation


Biospecimen Retention:   Samples With DNA
Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 2,300 adult patients diagnosed with myeloid disease will be enrolled in Connect® Myeloid Registry from 200 sites (both community [70-80%] and academic [20-30%] facilities) across the US that are representative of where patients with myeloid diseases are diagnosed and treated.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688011


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Publications:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01688011    
Other Study ID Numbers: AZA-MDS-006
Connect® MDS/AML Registry ( Other Identifier: BMS )
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024
Keywords provided by Celgene:
Myelodysplastic syndromes
MDS
Acute myeloid leukemia
AML
Registry
Connect®
 ICUS
Idiopathic Cytopenias of Undetermined Significance
Myelofibrosis
MF
Myelodysplastic/Myeloproliferative overlap syndromes
MDS/MPN overlap syndromes
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Primary Myelofibrosis
Syndrome
Disease
Pathologic Processes
 Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Myeloproliferative Disorders
Luspatercept
Hematinics