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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization through 1-year post first dose
Awards & highlights

COMMANDS Trial 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.Check my eligibility
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.See study design
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.

COMMANDS Trial 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.

COMMANDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization through 1-year post first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization through 1-year post first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Red blood cell transfusion independence (RBC-TI) for 12 weeks (84 days) with a mean hemoglobin increase ≥ 1.5 g/dL
Secondary outcome measures
Duration of RBC-TI ≥ 12 weeks (84 days)
Frequency of antidrug antibodies (ADA)
Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG)
+18 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%
Vomiting
13%
Nausea
13%
Abdominal pain
13%
Dizziness
13%
Myalgia
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%
Pain
6%
Urinary tract infection
6%
Viral upper respiratory tract infection
6%
Neck pain
6%
Osteoporosis
5%
Spinal pain
5%
Lethargy
5%
Injection site pain
5%
Menstruation irregular
5%
Alanine aminotransferase increased
5%
Constipation
5%
Transfusion reaction
5%
Liver iron concentration increased
4%
Musculoskeletal chest pain
4%
Fall
2%
Anaemia
1%
Deep vein thrombosis
1%
Extramedullary haemopoiesis
1%
Septic shock
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

COMMANDS 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
~1050

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
636 Previous Clinical Trials
128,608 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical reasons is Luspatercept commonly prescribed?

"Luspatercept is commonly used to treat conditions with a high risk of blood loss. Other conditions that Luspatercept can be effective against include surgical blood loss, hiv, and anemia."

Answered by AI

Is Luspatercept a common treatment in clinical trials?

"Currently, there are 32 active clinical trials testing Luspatercept. Of these ongoing studies, 12 have progressed to Phase 3. The majority of these investigations are taking place in Palma de Mallorca, Islas Baleares; however, there are 1666 locations worldwide where researchers are conducting these studies."

Answered by AI

When can patients in the United States expect to receive Luspatercept treatments?

"There is some data from prior clinical trials that suggest Luspatercept is effective, and because this is a Phase 3 trial, there is also multiple rounds of data that support its safety--so our team at Power gave it a score of 3."

Answered by AI

Are investigators still searching for volunteers for this research?

"From what is reflected on clinicaltrials.gov, this clinical trial is not currently looking for participants. This trial was originally posted on 1/2/2019 and was most recently updated on 10/24/2022. There are, however, 1894 other trials that are actively enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Alta Bates Summit Medical Center
UT Southwestern Simmons Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
Recent research and studies
clinicaltrials.govStudy
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
2019. "A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03682536.
All > Autoimmune Hemolytic Anemia > Myelodysplastic Syndrome
~58 spots leftby Apr 2025
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