drugset / Trial / NCT01380145
MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Phase 1
Completed
13 enrolled
Ludwig Institute for Cancer Research
Fox Chase Cancer Center · collabGlaxoSmithKline · collabMOUNT SINAI HOSPITAL · collabMemorial Sloan Kettering Cancer Center · collabNYU Langone Health · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | recMAGE-A3 | Protein / enzyme biologic | 300 ug | Intramuscular |
| Background | AS15 | Other / unclassified | — | Intramuscular |