WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
Multiple Myeloma, Minimal Residual Disease, High-Risk Cancer
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring WT1 Analog Peptide Vaccine, 12-288, Galinpepimut-S, GPS, Maintenance therapy, Autologous Stem Cell Transplant (ASCT), Lenalidomide, Immune Response, Wilms Tumor 1, Prevention of progression, Prevention of relapse, Immuno-Oncology, Immunotherapeutic Agent, Direct Immunizer, Heteroclitic, Multivalent, Post-ASCT maintenance, High-risk cytogenetics
Eligibility Criteria
Inclusion Criteria:
- Symptomatic multiple myeloma, ISS stage 1-3 with confirmed diagnosis of multiple myeloma at MSKCC
- Patients must be eligible to undergo autologous stem cell transplantation by standard institutional criteria
- Patients must have documented WT1 positive disease. For purpose of this study, this is defined as detectable presence of WT1 expression by immunohistochemistry or by WT1 transcript via RT-PCR on a bone marrow or other plasma cell-related biopsy specimen prior to autologous stem cell transplantation. Bone marrow or other biopsy specimen from time of diagnosis from patients diagnosed at MSKCC or outside hospital may be requested for assessment of WT1 expression by IHC
- Age > or = to 18 years
- Karnofsky performance status > or = to 50%
- Hematologic parameters:
- Absolute neutrophil count (ANC) > or = to 1,000/μl
- Platelets > 50,000/μl
- Biochemical parameters:
- Total bilirubin < than or = to 2.0 mg/dl
- AST and ALT < than or = to 2.5 x upper limits of normal (ULN)
- Creatinine < than or = to 2.0 mg/dl
Exclusion Criteria:
- Pregnant or lactating women
- Patients with active infection requiring systemic antimicrobials
- Patients taking systemic corticosteroids
- Patients with serious unstable medical illness
- Concurrent malignancies
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
vaccine
Galinpepimut-S (GPS) inoculations are started 12-22 d following autologous stem cell transplantation (ASCT). GPS (1.0 ml of emulsion) is given s.c. on weeks 0, 2, 4, 6, 8, & 10 (i.e., x 6). Injection sites are pre-stimulated with Sargramostim (GM-CSF; 70 μg) s.c. on d -2 (± 1 d ) & d 0 of each GPS inoculation. N.B.: during each GPS inoculation, the Sargramostim & GPS are administered to the same anatomical site. Subjects are observed for >/= 30 minutes after vaccination. Non-progressing subjects who are clinically stable (no active infection with fevers & no cardiovascular/respiratory compromise) may receive up to 6 more vaccinations q-month. The use of post-ASCT maintenance therapy with either lenalidomide or bortezomib is allowed starting >/= 3 months after ASCT.