WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
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.
|Multiple Myeloma||Biological: WT1 Analog Peptide Vaccine Biological: Sargramostim (GM-CSF) Drug: lenalidomide|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation|
- response [ Time Frame: 12-14 weeks after the initial WT1 peptide vaccine ]Immune responses to WT1 peptides will be measured by intracellular interferon-γ production assay and MHC tetramer analyses, if available for patient's HLA-type.
- disease-free survival [ Time Frame: 2 years ]
- overall survival [ Time Frame: 2 years ]
- toxicity profile [ Time Frame: 2 years ]Toxicity will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0) The only toxicities captured outside of the SAEs reported will be all Grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study.
- WT1 expression [ Time Frame: 2 years ]Protein expression analysis for WT antigens will be done by immunohistochemistry (IHC) as follows: Monoclonal antibodies to CD138/Syndecan, co-express WT1 when staining WT1 mAB 6F-H2 will employed by the study specified research lab on S-631.
|Actual Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Vaccinations will be initiated 12-22 days following autologous stem cell transplantation. Six vaccinations of the WT1 peptide preparation (1.0 ml of emulsion) will be administered on weeks 0, 2, 4, 6, 8, & 10. All vaccinations will be administered subcutaneously with vaccination sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF 70 μg) injected subcutaneously on days -2 (± 1 day) & 0 of each vaccination. Note: during each vaccination, the Sargramostim (GM-CSF)& the vaccine emulsion will be administered to the same anatomical site. Patients will be observed for at least 30 minutes after vaccination. Patients, who are clinically stable (no active infection with fevers & no cardiovascular or respiratory compromise) & have not had disease progression, may receive up to 6 more vaccinations administered appropriately every month. The use of post-stem cell transplant maintenance therapy is allowed starting 3 months or more after transplant.
Biological: WT1 Analog Peptide Vaccine
Biological: Sargramostim (GM-CSF)
Optional lenalidomide maintenance starting 3-months post auto SCT
Please refer to this study by its ClinicalTrials.gov identifier: NCT01827137
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Guenther Koehne, MD, PhD||Memorial Sloan Kettering Cancer Center|