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) MAXILUS

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 3

Enrollment: 100 patients (estimated)

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Trial Links

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Cancer and Blood Specialty Clinic

Los Alamitos, CA

Open and Accepting

Scripps Prebys Cancer Center

San Diego, CA

Not Yet Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Not Yet Accepting

Florida

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Not Yet Accepting

Florida Cancer Specialists - North - St. Petersburg North

St. Petersburg, FL

Not Yet Accepting

Sarah Cannon Research Institute FCS East - Wellington

Wellington, FL

Not Yet Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Not Yet Accepting

Kentucky

Mercy Health - Paducah Medical Oncology and Hematology

Paducah, KY

Not Yet Accepting

Massachusetts

UMass Memorial Medical Center - University Campus

Worcester, MA

Not Yet Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Not Yet Accepting

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Not Yet Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Not Yet Accepting

Ohio

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Not Yet Accepting

Oregon

Oncology Associates of Oregon

Eugene, OR

Not Yet Accepting

Pennsylvania

West Penn Hospital (Allegheny Health Network)

Pittsburgh, PA

Not Yet Accepting

Texas

Texas Oncology Amarillo Cancer Center

Amarillo, TX

Not Yet Accepting

North Houston Cancer Clinics - Huntsville

Huntsville, TX

Open and Accepting

West Virginia

Wheeling Hospital Schiffler Cancer Center

Wheeling, WV

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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