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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
Subject has Myeloproliferative neoplasm (MPN)-associated myelofibrosis (PMF, post- Post-polycythemia vera myelofibrosis (PV MF), and/or Post-essential thrombocythemia myelofibrosis (post-ET MF)) as confirmed from the most recent local bone marrow biopsy report according to the World Health Organization 2016 criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up c1d1 (pre-dose), c1d8, c1d15, c2d1, c4d1, c5d1, c5d8, c6d1, and c8d1, day 169, day 1 of every 4th extension phase treatment cycle for up to 1 year post the date of first dose of luspatercept, and end of treatment.
Awards & highlights
Study Summary
This trial is looking at a new drug to help people with myelofibrosis who are anemic and need transfusions. The study will last for a while and have different phases to evaluate safety and efficacy.
Eligible Conditions
- Anemia
- Primary Myelofibrosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ c1d1 (pre-dose), c1d8, c1d15, c2d1, c4d1, c5d1, c5d8, c6d1, and c8d1, day 169, day 1 of every 4th extension phase treatment cycle for up to 1 year post the date of first dose of luspatercept, and end of treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~c1d1 (pre-dose), c1d8, c1d15, c2d1, c4d1, c5d1, c5d8, c6d1, and c8d1, day 169, day 1 of every 4th extension phase treatment cycle for up to 1 year post the date of first dose of luspatercept, and end of treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Number of Participants With Anemia Responses Over Any 84-Day Period During the Primary Treatment Period
Secondary outcome measures
AUCss (Day* µg/mL)
CL/F (L/Day)
Cmax (µg/mL)
+17 moreSide effects data
From 2021 Phase 3 trial • 336 Patients • NCT0260443342%
Upper respiratory tract infection
35%
Headache
32%
Back pain
23%
Arthralgia
22%
Bone pain
22%
Cough
21%
Pyrexia
18%
Diarrhoea
18%
Oropharyngeal pain
17%
Fatigue
16%
Pharyngitis
15%
Pain in extremity
13%
Nausea
13%
Vomiting
13%
Myalgia
13%
Dizziness
13%
Abdominal pain
12%
Asthenia
11%
Abdominal pain upper
11%
Influenza
10%
Hypertension
9%
Dyspepsia
9%
Influenza like illness
9%
Musculoskeletal pain
9%
Nasal congestion
8%
Urticaria
8%
Gastroenteritis
8%
Nasopharyngitis
7%
Toothache
7%
Tonsillitis
7%
Hyperuricaemia
6%
Urinary tract infection
6%
Pain
6%
Viral upper respiratory tract infection
6%
Neck pain
6%
Osteoporosis
5%
Constipation
5%
Injection site pain
5%
Transfusion reaction
5%
Alanine aminotransferase increased
5%
Liver iron concentration increased
5%
Spinal pain
5%
Lethargy
5%
Menstruation irregular
4%
Musculoskeletal chest pain
4%
Fall
2%
Anaemia
1%
Transient ischaemic attack
1%
Cerebrovascular accident
1%
Cholangitis
1%
Cholecystitis acute
1%
Extramedullary haemopoiesis
1%
Septic shock
1%
Cellulitis
1%
Pneumonia
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Luspatercept + BSC
Placebo + BSC
Trial Design
1Treatment groups
Experimental Treatment
Group I: Luspatercept in subjects with MPN-associated myelofibrosisExperimental Treatment1 Intervention
Subjects across each of the cohorts (Cohort 1, Cohort 2, Cohort 3A, and Cohort 3B) will receive luspatercept.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luspatercept
2018
Completed Phase 3
~1050
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
633 Previous Clinical Trials
127,857 Total Patients Enrolled
11 Trials studying Anemia
1,420 Patients Enrolled for Anemia
Torsten Gerike, MDStudy DirectorCelgene
1 Previous Clinical Trials
309 Total Patients Enrolled
1 Trials studying Anemia
309 Patients Enrolled for Anemia
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,500 Previous Clinical Trials
3,367,478 Total Patients Enrolled
7 Trials studying Anemia
1,392 Patients Enrolled for Anemia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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