Status:
COMPLETED
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation
Lead Sponsor:
Sellas Life Sciences Group
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to assess the immune response after vaccination with a peptide vaccine called galinpepimut-S (or GPS) in a type of blood cancer called multiple myeloma. A protein called W...
Detailed Description
This is an early phase clinical study conducted in patients with newly diagnosed high-risk multiple myeloma to examine the effects of vaccination with galinpepimut-S (GPS) on clinical and immunobiolog...
Eligibility Criteria
Inclusion
- 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 1,000/μl
- Platelets \> 50,000/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 (ULN)
- Creatinine \< than or = to 2.0 mg/dl
Exclusion
- Pregnant or lactating women
- Patients with active infection requiring systemic antimicrobials
- Patients taking systemic corticosteroids
- Patients with serious unstable medical illness
- Concurrent malignancies
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01827137
Start Date
April 1 2013
End Date
November 6 2017
Last Update
September 19 2024
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065