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

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.

Conditions

Myelodysplastic Syndromes

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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)

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

Condition
Myelodysplastic Syndromes
Intervention / Treatment

-

Contacts and Locations

Los Alamitos

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States, 90720-3379

San Diego

Local Institution - 0048, San Diego, California, United States, 92103-2106

New Haven

Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States, 06510

Miami

Local Institution - 0042, Miami, Florida, United States, 33136

Saint Petersburg

Florida Cancer Specialists - NORTH - SCRI - PPDS, Saint Petersburg, Florida, United States, 33705

Wellington

Florida Cancer Specialists - SOUTH - SCRI - PPDS, Wellington, Florida, United States, 33414

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160-8500

Paducah

Mercy Health - Paducah Medical Oncology and Hematology, Paducah, Kentucky, United States, 42003-7915

Worcester

Local Institution - 0012, Worcester, Massachusetts, United States, 01655

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2027-12-30