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A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve (COMMANDS)

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ClinicalTrials.gov Identifier: NCT03682536
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
Acceleron Pharma Inc.
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Luspatercept Drug: Epoetin alfa Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Luspatercept Drug: Luspatercept
Specified dose on specified days
Other Name: ACE-536
Active Comparator: Epoetin alfa Drug: Epoetin alfa
Specified dose on specified days
Other Names:
  • EPREX®
  • ERYPO®
  • PROCRIT®


Outcome Measures
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Primary Outcome Measures :
  1. Red blood cell transfusion independence (RBC-TI) for 12 weeks (84 days) with a mean hemoglobin increase ≥ 1.5 g/dL [ Time Frame: Week 1 through Week 24 ]

Secondary Outcome Measures :
  1. RBC-TI for 24 weeks [ Time Frame: Week 1 through Week 24 ]
  2. Mean hemoglobin change over 24 weeks [ Time Frame: Week 1 through Week 24 ]
  3. Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG) [ Time Frame: Week 1 through Week 24 ]
  4. Time to HI-E [ Time Frame: Week 1 through Week 24 ]
  5. RBC-TI for ≥ 12 weeks (84 days) [ Time Frame: Week 1 through Week 24 ]
  6. Duration of RBC-TI ≥ 12 weeks (84 days) [ Time Frame: Week 1 through End of Treatment (EOT), up to approximately 60 months ]
  7. Time to RBC-TI ≥ 12 weeks (84 days) [ Time Frame: Week 1 through Week 24 ]
  8. Time to first red blood cell (RBC) transfusion [ Time Frame: Week 1 through EOT, up to approximately 60 months ]
  9. RBC transfusion burden on treatment [ Time Frame: Week 1 through Week 24 ]
  10. RBC-TI for ≥ 56 days (8 weeks) [ Time Frame: Week 1 through Week 24 ]
  11. RBC-TI for a consecutive 24-week period [ Time Frame: Week 1 through Week 48 ]
  12. The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) [ Time Frame: Screening through Week 24 ]
  13. The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire [ Time Frame: Screening through Week 24 ]
  14. Number of participants with Adverse Events (AEs) [ Time Frame: Week 1 through 42 days post last dose ]
  15. Pharmacokinetic - area under the concentration-time curve (AUC) [ Time Frame: Randomization through 1-year post first dose ]
  16. Pharmacokinetic - maximum plasma concentration of drug (Cmax) [ Time Frame: Randomization through 1-year post first dose ]
  17. Frequency of antidrug antibodies (ADA) [ Time Frame: Randomization through 1-year post first dose ]
  18. Number of participants progressing to acute myeloid leukemia (AML) [ Time Frame: Randomization through up to 60 months ]
  19. Percentage of participants progressing to AML [ Time Frame: Randomization through up to 60 months ]
  20. Time to AML progression [ Time Frame: Randomization through up to 60 months ]
  21. Overall survival [ Time Frame: Randomization through up to 60 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
  • Endogenous serum erythropoietin (sEPO) level of < 500 U/L
  • Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

Exclusion Criteria:

  • Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
  • Known history of diagnosis of Acute myeloid leukemia (AML)
  • Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment

Other protocol-defined inclusion/exclusion criteria apply

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): NCT03682536


Contacts
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Contact: BMS Study Connect Contact 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
Acceleron Pharma Inc.
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03682536    
Other Study ID Numbers: ACE-536-MDS-002
U1111-1218-1810 ( Registry Identifier: WHO )
2017-003190-34 ( EudraCT Number )
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Luspatercept
ACE-536
Anemia
Myelodysplastic Syndromes
Blood Transfusion
 RBC Transfusion
Erythropoiesis-stimulating agents
Erythropoietin
Myelodysplasia
Additional relevant MeSH terms:
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Preleukemia
Anemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Hematologic Diseases
 Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Epoetin Alfa
Luspatercept
Hematinics