drugset / Trial / NCT01380145

MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

NCT01380145

NaSingle-groupOpen-labelTreatment

Summary

This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the International Myeloma Working Group (IMWG) criteria and who were eligible for high-dose chemotherapy with autologous stem cell transplant (auto-SCT). The primary objective was to determine the safety and tolerability of immunizations when administered prior to stem cell mobilization and multiple times after stem cell reinfusion. Secondary objectives were to assess the humoral and cellular immunogenicity and clinical outcomes of immunization.

Timeline

Start
2011-09
Primary completion
2014-07
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject recMAGE-A3 Protein / enzyme biologic 300 ug Intramuscular
Background AS15 Other / unclassified Intramuscular

Indications