WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation

• Status: Active, not recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if the investigator can help the immune system to work against myeloma through the use/administration of a peptide vaccine (immunotherapy agent) directed against the Wilms Tumor 1 (WT1) protein called galinpepimut-S (or GPS, for brief). Because cancer is produced by the patient's own body, the immune system does not easily recognize and fight cancer cells. The immune system needs to be "trained" to do this; the latter goal is accomplished by using a vaccine consisting of selected fragments of the target antigen, in this case, WT1.

This disease has been selected for this study because the WT1 protein is often present in myeloma cells. WT1 is a gene that is involved in the normal development of kidneys and other organs. When the WT1 gene becomes abnormal, it can make proteins involved in the development of cancer, i.e., can acquire the properties of a true "oncogene". This study will determine whether the vaccine against the WT1 antigen (present in malignant plasmacytes) can cause an immune response which is safe, but also able to keep the myeloma from either coming back or progressing.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center; Sellas Life Sciences Group
• Treatments: Lenalidomide; Molgramostim; Sargramostim; Vaccines

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