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)

View More
Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

Trial Links

Read the latest news and updates on this trial.

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

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Florida

Florida Cancer Specialists - North - St. Petersburg North

St. Petersburg, FL

Open and Accepting

Sarah Cannon Research Institute FCS East - Wellington

Wellington, FL

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Kentucky

Mercy Health - Paducah Medical Oncology and Hematology

Paducah, KY

Open and Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Not Yet Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Oklahoma

INTEGRIS Cancer Institute Southwest Medical Center

Oklahoma City, OK

Not Yet Accepting

Oregon

Oncology Associates of Oregon

Eugene, OR

Open and Accepting

Pennsylvania

West Penn Hospital (Allegheny Health Network)

Pittsburgh, PA

Open and Accepting

Texas

Texas Oncology Amarillo Cancer Center

Amarillo, TX

Open and Accepting

West Virginia

Wheeling Hospital Schiffler Cancer Center

Wheeling, WV

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • Add this trial to your favorites keyboard_arrow_right

    If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message