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

Phase 3Active Not RecruitingNCT06045689

Bristol-Myers Squibb106 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Myelodysplastic Syndromes

Interventions

LuspaterceptDRUG

Specified dose on specified days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (52)

Outcomes

Primary Outcomes

Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24

Time frame: Up to week 24

Secondary Outcomes

Number of participants with a mean change in total RBC units transfused over a fixed 16-week period from Week 9 to Week 24 and from Week 33 to Week 48

Time frame: Up to week 48

Number of participants who have a time from first dose to first onset of RBC-TI ≥ 8-, 12-, and 16-weeks from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT

Time frame: Up to 2 years

Number of participants who achieve RBC-TI over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 to EOT

Time frame: Up to 2 years

Number of participants with a maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period from Week 1 to Week 24 and from Week 1 to EOT

Time frame: Up to 2 years

Number of participants who achieve RBC-TI over any consecutive 12-, 16-, and 24-week periods from Week 1 to Week 24, from Week 1 to Week 48 and from Week 1 through EOT

Time frame: Up to 2 years

Number of participants with an increase from baseline in mean hemoglobin (Hb) values of ≥ 1.0 g/dL over any consecutive 8-week period in absence of RBC transfusions from Week 1 to Week 48 and from Week 1 through EOT

Time frame: Up to 2 years

Number of participants with an increase from baseline in Hb values of ≥ 1.0 g/dL over any consecutive 16-week period in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT

Data from ClinicalTrials.gov

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Local Institution - 0051

Los Alamitos, California, United States

Local Institution - 0033

New Haven, Connecticut, United States

Local Institution - 0055

St. Petersburg, Florida, United States

Local Institution - 0056

Wellington, Florida, United States

Local Institution - 0020

Kansas City, Kansas, United States

Local Institution - 0025

Paducah, Kentucky, United States

Local Institution - 0011

Detroit, Michigan, United States

Local Institution - 0059

St Louis, Missouri, United States

Local Institution - 0058

Morristown, New Jersey, United States

Local Institution - 0032

New York, New York, United States

...and 42 more locations

Time frame: Up to 2 years

Number of participants with an increase from baseline in Hb values of ≥ 1.5 g/dL over any consecutive 8-, and 16-week periods in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT

Time frame: Up to 2 years

Number of participants who achieve Hematological Improvement Erythroid (mHI-E) per International Working Group-2018 (IWG-2018) over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT

Time frame: Up to 2 years

Number of participants who achieve Hematological Improvement - Neutrophils (HI-N) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT

Time frame: Up to 2 years

Number of participants who achieve Hematological Improvement - Platelets (HI-P) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT

Time frame: Up to 2 years

Number of participants with change in serum ferritin (SF) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48

Time frame: Up to week 48

Number of participants with change in mean daily dose of iron chelation therapy (ICT) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48

Time frame: Up to week 48

Number of participants with adverse events (AEs)

Time frame: Up to 2 years

Number of participants with acute myeloid leukemia (AML) progression

Time frame: Up to 4 years

Time to AML progression

Time frame: Up to 4 years

Time from treatment start date to death due to any cause

Time frame: Up to 4 years

Number of participants with a change in subscale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from Week 1 to Week 48 and from baseline through EOT

Time frame: Up to 2 years