WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
WT1 Analog Peptide Vaccine, 12-288
Study Type
Study Phase
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: WT1 Analog Peptide Vaccine Type: Biological
Name: Sargramostim (GM-CSF) Type: Biological
Name: lenalidomide Type: Drug
Overall Status
The purpose of this study is to see if the investigator can help the immune system to work against myeloma. Because cancer is produced by the patients own body, the immune system does not easily recognize and fight cancer cells. The immune system needs to be "trained" to do this.

This disease has been selected for this study because the Wilms Tumor 1 (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. This study will determine whether the WT1 vaccine causes an immune response which is safe and able to keep the myeloma from coming back.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 1000/μl

- Platelets > 50k/ 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

- 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
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Guenther Koehne, MD,PhD - 212-639-8599
Start Date
April 2013
Completion Date
April 2016
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page