MT2026-02: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (SWOG S2213)
The purpose of this study is to compare two treatment approaches for people with amyloidosis: daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) chemotherapy followed by an autologous stem cell transplant versus Dara-VCD followed by daratumumab maintenance therapy without a stem cell transplant.
• diagnosis of systemic amyloid light chain (AL) amyloidosis
• may receive up to one cycle (or 28 days) of therapy prior to starting the study
• may be receiving chronic corticosteroids if they are being given for other disorders
• must be willing to undergo high dose chemotherapy and autologous stem cell transplantation
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• other uncontrolled illnesses including diabetes, hypertension, heart or lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
Procedure: Autologous Hematopoietic Stem Cell Transplantation, Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Drug: Bortezomib, Procedure: Computed Tomography, Drug: Cyclophosphamide, Drug: Daratumumab and Hyaluronidase-fihj, Drug: Dexamethasone, Procedure: Echocardiography, Procedure: Magnetic Resonance Imaging, Drug: Melphalan, Procedure: Positron Emission Tomography, Procedure: Stem Cell Isolation, Other: Survey Administration
Cancer, Rare Diseases
Clinics and Surgery Center (CSC), amyloid light chain (AL) amyloidosis