| Titre |
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 |
| Protocole ID |
AFFIRM-AL (NEOD001-301) |
| ClinicalTrials.gov ID |
NCT04973137 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Birtamimab avec traitement standard versus placebo avec traitement standard |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Chaim Shustik
Dr Michael Sebag
|
| Coordonnateur(trice) |
Nancy Renouf
514-934-1934 poste 35718
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Aged ≥18 years
- Newly diagnosed and AL amyloidosis treatment-naïve 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 >0.03 ng/mL and dFLC ≥18 mg/dL
- Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly.
|
| Critètes d'exclusion |
- Non-AL amyloidosis.
- NT-proBNP >8500 pg/mL.
- Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma
- 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 <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
|
Groupe d'étude en oncologie du Québec