Pilot Study of recMAGE-A3 + AS15 ASCI as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Open label, single arm pilot study of recombinant MAGE-A3 protein plus AS15 Adjuvant
(recMAGE-A3 + AS15 ASCI) in 16 patients with symptomatic multiple myeloma, ISS stage 1, 2 or
3, who have completed induction therapy with at least Very Good Partial Response (VGPR) by
International Myeloma Working Group (IMWG) criteria, and who are eligible for high dose
chemotherapy with autologous stem cell transplant (auto-SCT) by standard institutional
criteria. MAGE-A3 tumor antigen expression will be required for study entry. Patients will
receive 8 immunizations over 320 days, with the first immunizations given approximately 6
weeks before auto-SCT, and the rest given post-SCT
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess safety and tolerability according to the National Cancer Institute CTCAE v4.0
Laboratory tests, vital sign measurements, physical exams and patient histories will be performed to detect new abnormalities and deteriorations of any pre-existing conditions
Up to 14 months
Yes
Hearn J Cho, MD, PhD
Study Chair
Mount Sinai School of Medicine
United States: Food and Drug Administration
LGS 2009-005
NCT01380145
June 2011
May 2014
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Mount Sinai School of Medicine | New York, New York 10029 |
New York University Cancer Institute | New York, New York 10016 |