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A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants (MAXILUS)

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ClinicalTrials.gov Identifier: NCT06045689
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)
Actual Study Start Date : October 5, 2023
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : December 30, 2027

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: erythropoiesis-stimulating agents (ESA) naïve Drug: Luspatercept
Specified dose on specified days.
Other Names:
  • BMS-986346
  • ACE-536
  • REBLOZYL
Experimental: Cohort 2: ESA relapsed or refractory Drug: Luspatercept
Specified dose on specified days.
Other Names:
  • BMS-986346
  • ACE-536
  • REBLOZYL


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24 [ Time Frame: Up to week 24 ]

Secondary Outcome Measures :
  1. Number of participants with a mean change in total RBC units transfused over a fixed 16-week period from Week 9 to Week 24 and from Week 33 to Week 48 [ Time Frame: Up to week 48 ]
  2. Number of participants who have a time from first dose to first onset of RBC-TI ≥ 8-, 12-, and 16-weeks from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT [ Time Frame: Up to 2 years ]
  3. Number of participants who achieve RBC-TI over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 to EOT [ Time Frame: Up to 2 years ]
  4. Number of participants with a maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period from Week 1 to Week 24 and from Week 1 to EOT [ Time Frame: Up to 2 years ]
  5. Number of participants who achieve RBC-TI over any consecutive 12-, 16-, and 24-week periods from Week 1 to Week 24, from Week 1 to Week 48 and from Week 1 through EOT [ Time Frame: Up to 2 years ]
  6. Number of participants with an increase from baseline in mean hemoglobin (Hb) values of ≥ 1.0 g/dL over any consecutive 8-week period in absence of RBC transfusions from Week 1 to Week 48 and from Week 1 through EOT [ Time Frame: Up to 2 years ]
  7. Number of participants with an increase from baseline in Hb values of ≥ 1.0 g/dL over any consecutive 16-week period in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT [ Time Frame: Up to 2 years ]
  8. Number of participants with an increase from baseline in Hb values of ≥ 1.5 g/dL over any consecutive 8-, and 16-week periods in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT [ Time Frame: Up to 2 years ]
  9. Number of participants who achieve Hematological Improvement Erythroid (mHI-E) per International Working Group-2018 (IWG-2018) over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT [ Time Frame: Up to 2 years ]
  10. Number of participants who achieve Hematological Improvement - Neutrophils (HI-N) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT [ Time Frame: Up to 2 years ]
  11. Number of participants who achieve Hematological Improvement - Platelets (HI-P) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT [ Time Frame: Up to 2 years ]
  12. Number of participants with change in serum ferritin (SF) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48 [ Time Frame: Up to week 48 ]
  13. Number of participants with change in mean daily dose of iron chelation therapy (ICT) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48 [ Time Frame: Up to week 48 ]
  14. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
  15. Number of participants with acute myeloid leukemia (AML) progression [ Time Frame: Up to 4 years ]
  16. Time to AML progression [ Time Frame: Up to 4 years ]
  17. Time from treatment start date to death due to any cause [ Time Frame: Up to 4 years ]
  18. Number of participants with a change in subscale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from Week 1 to Week 48 and from baseline through EOT [ Time Frame: Up to 2 years ]

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:

  • Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
  • Participant must have red blood cell transfusions according to study criteria.

Exclusion Criteria:

  • Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
  • Participant has had a prior allogeneic or autologous stem cell transplant.
  • Participant has known history or diagnosis of AML.
  • Participant has uncontrolled hypertension.

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): NCT06045689


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

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
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: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT06045689    
Other Study ID Numbers: CA056-1060
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: May 6, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bristol-Myers Squibb:
Luspatercept
Transfusion dependent
ACE-536
Anemia
 Blood Transfusion
Red Blood Cell Transfusion
Myelodysplastic Syndrome
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Neoplasms
Luspatercept
Hematinics