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Erythropoiesis Stimulating Agent

Luspatercept vs Epoetin Alfa for MDS-related Anemia (COMMANDS Trial)

Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
Must not have
Known history of diagnosis of Acute myeloid leukemia (AML)
Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (up to approximately 221 weeks)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare luspatercept to epoetin alfa to see if luspatercept is more effective in increasing hemoglobin and reducing the need for RBC transfusions in patients with anemia due to MDS.

Who is the study for?
This trial is for people with very low to intermediate risk Myelodysplastic Syndromes (MDS) who need regular blood transfusions and have never used an ESA. They should have less than 5% bone marrow blasts, be relatively active (ECOG score of 0-2), and not suffer from other causes of anemia or conditions like uncontrolled high blood pressure or Acute myeloid leukemia.
What is being tested?
The study compares Luspatercept (ACE-536) with Epoetin alfa in treating anemia caused by MDS. It aims to see if patients can avoid red blood cell transfusions for at least 12 weeks while also increasing their hemoglobin levels by at least 1.5 g/dL.
What are the potential side effects?
Possible side effects include headache, hypertension, joint pain, dizziness, nausea, fatigue, reactions at the injection site for both drugs; more specific side effects related to each drug may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a type of blood disorder called MDS, with a low to intermediate risk and less than 5% cancer cells in my bone marrow.
Select...
I've needed 2-6 blood transfusions every 8 weeks for the last 2 months.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with Acute myeloid leukemia (AML).
Select...
My high blood pressure is not controlled even with treatment.
Select...
I have anemia caused by a deficiency, autoimmune condition, or medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (up to approximately 221 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (up to approximately 221 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL
Secondary study objectives
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)
Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An)
Duration of Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days)
+15 more

Side effects data

From 2021 Phase 3 trial • 336 Patients • NCT02604433
42%
Upper respiratory tract infection
35%
Headache
32%
Back pain
23%
Arthralgia
22%
Bone pain
22%
Cough
21%
Pyrexia
18%
Oropharyngeal pain
18%
Diarrhoea
17%
Fatigue
16%
Pharyngitis
15%
Pain in extremity
13%
Abdominal pain
13%
Nausea
13%
Vomiting
13%
Myalgia
13%
Dizziness
12%
Asthenia
11%
Abdominal pain upper
11%
Influenza
10%
Hypertension
9%
Dyspepsia
9%
Influenza like illness
9%
Musculoskeletal pain
9%
Nasal congestion
8%
Nasopharyngitis
8%
Gastroenteritis
8%
Urticaria
7%
Toothache
7%
Tonsillitis
7%
Hyperuricaemia
6%
Pain
6%
Urinary tract infection
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%
Spinal pain
5%
Lethargy
5%
Menstruation irregular
5%
Liver iron concentration increased
4%
Fall
4%
Musculoskeletal chest pain
2%
Anaemia
1%
Septic shock
1%
Extramedullary haemopoiesis
1%
Deep vein thrombosis
1%
Transient ischaemic attack
1%
Cerebrovascular accident
1%
Cholangitis
1%
Cholecystitis acute
1%
Cellulitis
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Luspatercept + BSC
Placebo + BSC

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LuspaterceptExperimental Treatment1 Intervention
Group II: Epoetin alfaActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luspatercept
2018
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Industry Sponsor
32 Previous Clinical Trials
3,904 Total Patients Enrolled
CelgeneLead Sponsor
645 Previous Clinical Trials
130,077 Total Patients Enrolled
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAIndustry Sponsor
32 Previous Clinical Trials
3,904 Total Patients Enrolled
~53 spots leftby Nov 2025
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