The AFFIRM-AL study is now enrolling adults 18 years of age or older with AL amyloidosis. Participants must be in Mayo Stage IV and have not yet received any medical treatment for AL amyloidosis.
AL amyloidosis is a rare disease that occurs when an abnormal protein, called amyloid, builds up and interferes with normal organ function. One classification system used to stage the prognosis of AL amyloidosis is the Mayo Staging system, a classification system for newly diagnosed patients. Specific laboratory tests determine the stage. Mayo Stage IV is one of the stages within this system.
The AFFIRM-AL study is a phase 3 clinical research study evaluating an investigational drug called birtamimab to find out if it works and if it is safe when given with chemotherapy to people with AL amyloidosis who are in Mayo Stage IV.
A Phase 3 clinical research study is the final phase of research evaluating an investigational drug’s effectiveness and safety before it can be approved for use in the general patient population.
Birtamimab is being tested in adults who are newly diagnosed with AL amyloidosis and are in Mayo Stage IV.
Study participants will receive either the investigational drug and standard of care chemotherapy or placebo and standard of care chemotherapy. Placebo is a substance that looks like the investigational drug but has no active drug in it. In this study, the placebo is saline.
You may potentially be eligible to participate in AFFIRM-AL if:
- You are 18 years of age (and legal age of consent) or older
- You are newly diagnosed with Mayo Stage IV AL amyloidosis
- You have not yet received any medical treatment for AL amyloidosis
This is not a complete list of study requirements. Your doctor will review all requirements with you.
The interactive map below shows the countries and cities of the study centers that are actively participating in the AFFIRM-AL study. The list shows the study centers within the United States first. To view other countries, please scroll down.
To view a country on the interactive map:
- You can either click on the + sign (bottom left) to zoom in on an area
- Click the pin to view the name and location of the study center, or you can move your mouse over the map
- Click down on your mouse, to move the map to the left, the right, or up and down. If you’re using a Smartphone or tablet, use your finger to move the map around.
Please note, this list may not include all participating study centers. Please refer to ClinicalTrials.gov/NCT04973137 to view the most up-to-date list of participating study centers.
Before a new therapy can be made available to the general patient population, multiple studies involving patient volunteers must be conducted to evaluate the safety and effectiveness of the therapy. These studies, referred to as clinical trials, are regulated by the Food and Drug Administration (FDA) in the United States and by similar regulatory agencies worldwide.
Participation in the AFFIRM-AL study will help us understand whether the investigational drug, birtamimab, is effective and safe for adults with newly diagnosed AL Amyloidosis in Mayo Stage IV.
Taking part in a clinical study is voluntary. If you are eligible to enroll, you may choose to join the study but leave at a later date for any reason at any time. Regardless of whether you choose to enroll or leave the study early, your future healthcare won’t be affected.