Abstract
TPS8111 Background: MAGE-A3 is a cancer-testis antigen (CT Ag) commonly expressed in MM but not in normal non-gonadal tissues. MAGE-A3 inhibited p53-dependent and independent apoptosis in MM cells (Clin Cancer Res 2011;17:4309), and spontaneous immunity against CT Ags in MM patients was associated with favorable clinical outcomes (Blood 2007;109:1103; Blood 2008;112:3362), making it a rational target for immunotherapy. In this study (NCT01380145), we are examining if a recombinant (rec) MAGE-A3 protein vaccine + adjuvant combined with vaccine-primed peripheral blood lymphocytes (PBL) can safely stimulate antigen-specific immunity in MM patients undergoing autoSCT for consolidation therapy. Methods: Patients meeting the following criteria are eligible: within 12 months of diagnosis; MAGE-A+ MM cells by immunohistochemistry; achieving at least a very good partial response with induction therapy; and meeting institutional criteria for autoSCT. One patient of a planned cohort of sixteen has been enrolled. Six weeks before SCT, subjects will receive their first vaccination (300 μg IM) and three weeks later undergo leukopheresis to collect vaccine-primed PBL. They then undergo stem cell mobilization followed by a standard melphalan-conditioned autoSCT. On day 3 after stem cell infusion, the unmanipulated, primed PBL will be re-infused followed by the second recMAGE-A3 vaccination on day 10. An additional six vaccinations will be administered on days 31, 52, 73, 94, 180, and 270 after autoSCT. The primary objectives are safety and tolerability. The secondary objectives of cellular and humoral immune responses and lymphocyte reconstitution will be assessed by a validated series of quantitative assays using established response criteria (PNAS 2008;105:1650). Success criteria based on immune response have not been specified for this pilot study, though induction of MAGE-A3 immunity in at least 50% of patients would merit consideration for further evaluation of clinical efficacy.
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