Clinical Trial Goal
To find out if epoetin alfa and luspatercept are safe and work well to treat low or intermediate-risk MDS
You may be able to join this trial if you:
- Are 18 years or older
- Have MDS that doctors consider low or intermediate-risk
- Do not require blood transfusions
- Have not been treated with an erythropoiesis stimulating agent (ESA). Your doctor can tell you this
- Do not have any of the following:
- Acute myeloid leukemia (AML)
- Pure red cell aplasia
- Secondary MDS
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Epoetin alfa is a type of protein that tells your bone marrow to produce more red blood cells.
Luspatercept is a small molecule inhibitor that blocks TGF-beta in certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in
Luspatercept is a small molecule inhibitor that blocks TGF-beta in certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in
- Group 1 – Epoetin alfa
- Group 2 – Luspatercept
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get:
- Epoetin alfa – Given as a shot under your skin. The dose you'll get depends on when you start the trial and how safe it has been
- Luspatercept – Given as a shot under your skin. The dose you'll get depends on when you start the trial and how safe it has been
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat low or intermediate-risk MDS is new and unproven.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
Locations
Sponsors
lead: Bristol-Myers Squibb
