Light Chain (AL) Amyloidosis
Conditions
Interventions
- Birtamimab group:
Intravenous administration of 24 mg/kg birtamimab every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) accordin
Sponsors
Nie Christie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria for Double-blind Phase: - 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 or high sensitivity cardiac troponin and dFLC >=18 mg/dL - Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly. Inclusion Criteria for Open-label (OLE) Phase: - Must not have discontinued treatment in Double-blind Phase - Women of childbearing potential must have a negative pregnancy test and must agree to use highly effective contraception through 90 days following last study drug administration - Male subjects must be surgically sterile or agree to use highly effective contraception through 90 days following last study drug administration - Ability to understand and willingness to sign an ICF prior to initiating the OLE Phase
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria for Double-blind Phase: - Non-AL amyloidosis. - NT-proBNP >8500 pg/mL. - Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma except for malignancy biomarker of involved /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. - Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area =3 infusion-related AEs during the Double-blind Phase or hypersensitivity to birtamimab - Unable or unwilling to adhere to the study-specified procedures and restrictions - Planning to use any other investigational treatment during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to all-cause mortality for the Double-blind Phase | — |
Secondary
| Measure | Time frame |
|---|---|
| - 6MWT distance for the Double Blind Phase - Physical Component Summary score of the Short Form-36, version 2 for the Double Blind Phase | — |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Republic of Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical contact
ICON Clinical Research GK
Outcome results
None listed