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A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis
EU CTIS ID: 2024-511066-36-00
What this study is testing
Double-blind Phase To evaluate the efficacy of birtamimab plus standard of care compared to placebo plus standard of care when administered intravenously in Mayo Stage IV subjects with AL amyloidosis by assessing time to all-cause mortality. Open-label Extension Phase To evaluate the long-term safety of birtamimab plus standard of care in Mayo Stage IV subjects with AL amyloidosis
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥18 years and legal age of consent according to local regulations
- Newly diagnosed and AL amyloidosis treatment naive with cardiac involvement
- Confirmed diagnosis of AL amyloidosis
- Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥ 1800 pg/mL and Troponin-T ≥0.025 ng/mL (mcg/L) or high sensitivity cardiac troponin T ≥40 ng/L and dFLC ≥18 mg/dL
- Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly
You likely can't join if
- Non-AL amyloidosis
- Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
- ECG evidence of acute ischemia or active conduction system abnormalities
- Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1
- Prior radiotherapy within 4 weeks of Month 1-Day 1
- Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11-1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid
See the full eligibility criteria
- Aged ≥18 years and legal age of consent according to local regulations
- Newly diagnosed and AL amyloidosis treatment naive with cardiac involvement
- Confirmed diagnosis of AL amyloidosis
- Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥ 1800 pg/mL and Troponin-T ≥0.025 ng/mL (mcg/L) or high sensitivity cardiac troponin T ≥40 ng/L and dFLC ≥18 mg/dL
- Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly
- Non-AL amyloidosis
- Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
- ECG evidence of acute ischemia or active conduction system abnormalities
- Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1
- Prior radiotherapy within 4 weeks of Month 1-Day 1
- Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11-1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid
- Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy
- NT-proBNP >8500 pg/mL
- Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma, except for malignancy biomarker of involved/and uninvolved serum free light chain ratio ≥100
- Subject is eligible for and plans to undergo ASCT or organ transplant during the study
- Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Korea, Republic of
- United States
- Taiwan
- Turkey
- United Kingdom
- Canada
- Australia
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Korea, Republic of; United States; Taiwan; Turkey; United Kingdom and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.