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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01827137
First received: April 2, 2013
Last updated: August 19, 2014
Last verified: August 2014

April 2, 2013
August 19, 2014
April 2013
April 2015   (final data collection date for primary outcome measure)
response [ Time Frame: 12-14 weeks after the initial WT1 peptide vaccine ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01827137 on ClinicalTrials.gov Archive Site
  • disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • toxicity profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Toxicity will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0)
  • WT1 expression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.
  • disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • toxicity profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Toxicity will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0)
  • WT1 expression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 Ludwig Institute of Cancer Research.
Not Provided
Not Provided
 
WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
A Pilot Trial of a 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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Biological: WT1 Analog Peptide Vaccine
  • Biological: Sargramostim (GM-CSF)
  • Drug: lenalidomide
    Optional lenalidomide maintenance starting 3-months post auto SCT
Experimental: vaccine
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 & 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 with lenalidomide is allowed starting 3 months or more after transplant.
Interventions:
  • Biological: WT1 Analog Peptide Vaccine
  • Biological: Sargramostim (GM-CSF)
  • Drug: lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Guenther Koehne, MD PhD 212-639-8599
Contact: Sergio Giralt 212-639-6009
United States
 
NCT01827137
12-288
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Guenther Koehne, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP