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Monoclonal Antibodies

Birtamimab for Amyloidosis (AFFIRM-AL Trial)

Phase 3
Recruiting
Research Sponsored by Prothena Biosciences Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥1800 pg/mL and Troponin-T ≥0.025 ng/mL or high sensitivity cardiac troponin T≥40ng/L and dFLC ≥18 mg/dL
Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 9
Awards & highlights

AFFIRM-AL Trial Summary

This trial is testing a new treatment for amyloidosis, a disease where amyloid protein builds up in the body's organs.

Who is the study for?
This trial is for adults with Mayo Stage IV AL Amyloidosis, a condition affecting the heart due to abnormal protein deposits. Participants must be newly diagnosed, treatment-naïve with specific cardiac involvement markers, and planning first-line chemotherapy including bortezomib. Those eligible for transplants or having other conditions like multiple myeloma or recent heart issues cannot join.Check my eligibility
What is being tested?
The study compares the effectiveness of Birtamimab plus standard chemotherapy against a placebo combined with standard chemotherapy in treating AL Amyloidosis patients at an advanced stage. It's designed to see if Birtamimab can improve patient outcomes.See study design
What are the potential side effects?
While not specified here, treatments like Birtamimab may cause side effects such as allergic reactions, infusion-related symptoms, fatigue, nausea, and could potentially worsen underlying heart conditions.

AFFIRM-AL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tests show I have advanced AL Amyloidosis with specific heart and blood markers.
Select...
My first chemotherapy will include weekly bortezomib shots.
Select...
I have been diagnosed with AL amyloidosis.
Select...
I have newly diagnosed AL amyloidosis with heart involvement and haven't received treatment.

AFFIRM-AL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to all-cause mortality for the Double Blind Phase
Secondary outcome measures
6MWT distance for the Double Blind Phase
Physical Component Summary score of the Short Form-36, version 2 for the Double Blind Phase

AFFIRM-AL Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Birtamimab plus Standard of Care Chemotherapy- For Double-blind Phase and OLE Phase of studyExperimental Treatment2 Interventions
Intravenous administration of 24 mg/kg birtamimab every 28 days. Drug: Standard of Care Chemotherapy. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care. The initiation of daratumumab treatment at randomization is allowed at the discretion of the Investigator; initiation at any other time during the Double-blind Phase is prohibited. For subjects who did not initiate daratumumab at randomization during the Double-blind Phase, daratumumab may be initiated at any time during the OLE Phase at the Investigator's discretion.
Group II: Placebo plus Standard of Care Chemotherapy- For Double-blind Phase of studyPlacebo Group2 Interventions
Intravenous 0.9% Saline administration as a placebo every 28 days. Drug: Standard of Care Chemotherapy. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care. Initiation of daratumumab at randomization allowed at the discretion of the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care Chemotherapy
2014
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Prothena Biosciences Ltd.Lead Sponsor
6 Previous Clinical Trials
915 Total Patients Enrolled
6 Trials studying Amyloidosis
915 Patients Enrolled for Amyloidosis

Media Library

Birtamimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04973137 — Phase 3
Amyloidosis Research Study Groups: Birtamimab plus Standard of Care Chemotherapy- For Double-blind Phase and OLE Phase of study, Placebo plus Standard of Care Chemotherapy- For Double-blind Phase of study
Amyloidosis Clinical Trial 2023: Birtamimab Highlights & Side Effects. Trial Name: NCT04973137 — Phase 3
Birtamimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04973137 — Phase 3

Frequently Asked Questions

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

In how many different medical clinics is this research project being run today?

"At the moment, this trial is taking place in 22 different medical centres. These include locations in Milwaukee, Knoxville and Rochester amongst other urban areas. If you enroll in this study, it would be best to choose a site that is close to your residence to limit travel time requirements."

Answered by AI

Is this clinical trial still looking for participants?

"That is correct. The information available on clinicaltrials.gov indicates that this study is still recruiting patients. This particular trial was posted on 8/30/2021 and updated as recently as 9/6/2022. They are looking for a total of 150 participants from 22 different sites."

Answered by AI

How many patients are being accepted into this trial?

"To move forward, this study requires 150 enrollees that meet the specific inclusion criteria. There are a few locations where patients can receive treatment, such as Froedtert and Medical College of Wisconsin in Milwaukee, Wisconsin and University of Tennessee Medical Center in Knoxville, Tennessee."

Answered by AI

Does this research have any historical precedent?

"Birtamimab's clinical trials began in 2021. The first Phase 1 study was sponsored by Prothena Biosciences Ltd.. After the successful completion of this initial trial on 150 patients, Birtamimab entered Phase 3 and was eventually approved for use. As of now, there is one ongoing study being conducted on the drug which is again sponsored by Prothena Biosciences Ltd.."

Answered by AI

Are there any similar investigations to the one being conducted with Birtamimab?

"Birtamimab is being investigated in 1 clinical trial that is currently ongoing. Additionally, there are 125 different locations around the world conducting trials for Birtamimab."

Answered by AI

Has Birtamimab been cleared by the FDA?

"There is existing clinical data that suggests Birtamimab is safe for human use, which is why it was given a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Johns Hopkins University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
2021. "A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04973137.
All > Al Amyloidosis > Amyloidosis
~64 spots leftby Jun 2025
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