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 :
Active, not recruiting
First Posted : September 24, 2018
Last Update Posted : November 21, 2022
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Sponsor:
Celgene
Collaborator:
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Information provided by (Responsible Party):
Celgene
Tracking Information | |||||
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First Submitted Date ICMJE | September 7, 2018 | ||||
First Posted Date ICMJE | September 24, 2018 | ||||
Last Update Posted Date | November 21, 2022 | ||||
Actual Study Start Date ICMJE | January 2, 2019 | ||||
Estimated Primary Completion Date | February 9, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE |
Red Blood Cell Transfusion Independence (RBCTI) for 24 weeks [ Time Frame: Randomization through Week 24 ] Proportion of subjects who are RBC transfusion free over the first 24 weeks from randomization
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 | ||||
Official Title ICMJE | 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 | ||||
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). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Myelodysplastic Syndromes | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
347 | ||||
Original Estimated Enrollment ICMJE |
350 | ||||
Estimated Study Completion Date ICMJE | February 14, 2028 | ||||
Estimated Primary Completion Date | February 9, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Netherlands, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03682536 | ||||
Other Study ID Numbers ICMJE | ACE-536-MDS-002 U1111-1218-1810 ( Registry Identifier: WHO ) 2017-003190-34 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Celgene | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Celgene | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | ||||
Investigators ICMJE |
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PRS Account | Celgene | ||||
Verification Date | November 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |