ACTIVE_NOT_RECRUITING

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

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Conditions

Myelodysplastic SyndromesLuspaterceptTransfusion dependentACE-536AnemiaBlood TransfusionRed Blood Cell TransfusionMyelodysplastic Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2023-10-05
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06045689

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
  3. * Participant must have red blood cell transfusions according to study criteria.
  1. * Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
  2. * Participant has had a prior allogeneic or autologous stem cell transplant.
  3. * Participant has known history or diagnosis of AML.
  4. * Participant has uncontrolled hypertension.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0051
Los Alamitos, California, 90720-3309
United States
Local Institution - 0033
New Haven, Connecticut, 06510
United States
Local Institution - 0055
Saint Petersburg, Florida, 33705
United States
Local Institution - 0056
Wellington, Florida, 33414
United States
Local Institution - 0020
Kansas City, Kansas, 66160-8500
United States
Local Institution - 0025
Paducah, Kentucky, 42003-7915
United States
Local Institution - 0011
Detroit, Michigan, 48202
United States
Local Institution - 0059
Saint Louis, Missouri, 63110
United States
Local Institution - 0058
Morristown, New Jersey, 07960-6136
United States
Local Institution - 0032
New York, New York, 10029
United States
Local Institution - 0054
Eugene, Oregon, 97401-6043
United States
Local Institution - 0036
Pittsburgh, Pennsylvania, 15224
United States
Local Institution - 0043
Amarillo, Texas, 79106-1781
United States
Local Institution - 0022
Huntsville, Texas, 77340-4101
United States
Local Institution - 0031
Wheeling, West Virginia, 26003
United States
Local Institution - 0003
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-05
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2023-10-05
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • Luspatercept
  • Transfusion dependent
  • ACE-536
  • Anemia
  • Blood Transfusion
  • Red Blood Cell Transfusion
  • Myelodysplastic Syndrome

Additional Relevant MeSH Terms

  • Myelodysplastic Syndromes