Luspatercept + Darbepoetin in MDS

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

May 31, 2030

Study Completion Date

May 31, 2030

Conditions
MDS (Myelodysplastic Syndrome)
Interventions
DRUG

Luspatercept

Luspatercept will be administered every 3 weeks (21 days) at a starting dose of 1.0 mg/kg (Dose Level 0). Luspatercept will be administered to participants by the study staff at the clinical site and administration will be documented in the participant's source record. Participants must have Hgb, blood pressure and weight assessed (changes of body weight of ≤ ± 5% do not require a dose adjustment) prior to each luspatercept dose administration. Subcutaneous injections will be given in the upper arm, thigh, and/or abdomen. Volume for subcutaneous injection will be per institutional standard/guidelines.

DRUG

Darbeopoetin

Darbepoetin alfa will be administered every 3 weeks (21 days), at a starting dose of 300 ug (Dose Level 0). Darbepoetin alfa will be administered to participants by the study staff at the clinical site and administration will be documented in the participant's source record. Darbepoetin alfa will be administered as a subcutaneous injection by the site staff in the upper arm, thigh, and/or abdomen per institutional standard/guidelines.

Trial Locations (1)

06510

Yale University, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Yale University

OTHER