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A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation


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 performed at MSKCC prior to autologous stem
cell transplantation. Bone marrow specimen from time of diagnosis from patients
diagnosed at MSKCC or OSH 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response

Outcome Description:

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.

Outcome Time Frame:

12-14 weeks after the initial WT1 peptide vaccine

Safety Issue:

No

Principal Investigator

Guenther Koehne, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-288

NCT ID:

NCT01827137

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Multiple Myeloma
  • WT1 Analog Peptide Vaccine
  • 12-288
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021