Phase 2
Completed N=20
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation
Source: ClinicalTrials.gov NCT01827137 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: WT1 T-cell Immune Response (IR) 12-14 Weeks After First GPS Administration (6 x Administrations) — 9 Participants
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 WT1 is often present in cancerous cells and GPS can train the immune system to recognize and kill the cancerous cells containing WT1. This study will also assess the safety of GPS, effect on disease, and on survival.
Participants who has undergone autologous stem cell transplant (ASCT) will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). Vaccinations will start 12 to 22 days after ASCT. In the absence of disease progression and if clinically stable after the first 6 vaccinations, participants may continue to receive six more vaccinations every month. The use of post-ASCT maintenance therapy is allowed starting from 3 months after transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WT1 T-cell Immune Response (IR) 12-14 Weeks After First GPS Administration (6 x Administrations) |
9 | — |
| SECONDARY Progression-free Survival (PFS) From Autologous Stem Cell Transplant (ASCT) |
717 | — |
| SECONDARY Overall Survival (OS) From Autologous Stem Cell Transplant (ASCT) |
NA | — |
Eligibility 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 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 Criteria
- Pregnant or lactating women
- Patients with active infection requiring systemic antimicrobials
- Patients taking systemic corticosteroids
- Patients with serious unstable medical illness
- Concurrent malignancies
Data sourced from ClinicalTrials.gov (NCT01827137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.