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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Myelodysplastic Syndromes

Treatments: Drug: Luspatercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT06045689

CA056-1060

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cohort 1: erythropoiesis-stimulating agents (ESA) naïve

Experimental group

Treatment:

Drug: Luspatercept

Cohort 2: ESA relapsed or refractory

Experimental group

Treatment:

Drug: Luspatercept