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
  Purpose

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.


Condition Intervention
Multiple Myeloma
Biological: WT1 Analog Peptide Vaccine
Biological: Sargramostim (GM-CSF)
Drug: lenalidomide

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: WT1 Analog Peptide Vaccine Biological: Sargramostim (GM-CSF) Drug: lenalidomide
Optional lenalidomide maintenance starting 3-months post auto SCT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827137

Contacts
Contact: Guenther Koehne, MD PhD 212-639-8599
Contact: Sergio Giralt 212-639-6009

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Guenther Koehne, MD,PhD    212-639-8599      
Contact: Sergio Giralt, MD    212-639-6009      
Principal Investigator: Guenther Koehne, MD, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Guenther Koehne, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01827137     History of Changes
Other Study ID Numbers: 12-288
Study First Received: April 2, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
WT1 Analog Peptide Vaccine
12-288

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014