Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01827137
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
2013-04-02
Brief Title:
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation
Sponsor:
Sellas Life Sciences Group
Organization:
Sellas Life Sciences Group
Study Overview
Official Title:
A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 immunobiological indices The study is titled A Pilot Trial of a WT1 Analog Peptide Vaccine Galinpepimut-S in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation and is designed as a single-arm single-institution open-label study The primary objective is to assess immune response 12 to 14 weeks after administration of GPS in patients with new diagnosed multiple myeloma MM following autologous stem cell transplant ASCT Secondary objective includes assessing the safety profile progression-free survival and overall survival
Galinpepimut-S GPS consists of four WT1-derived peptides which have been chosen to strengthen antigenicity but also broaden immunogenicity over a wide range of HLA subtypes being able to stimulate both CD8 MHC Class I- and CD4 MHC Class II-dependent responses Galinpepimut-S is administered with the adjuvant Montanide and sargramostim GM-CSF
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 with immunomodulatory drugs IMIDs eg thalidomide lenalidomide or proteasome inhibitors PSIs eg bortezomib is allowed from 3 months after transplant
Galinpepimut-S GPS consists of four WT1-derived peptides which have been chosen to strengthen antigenicity but also broaden immunogenicity over a wide range of HLA subtypes being able to stimulate both CD8 MHC Class I- and CD4 MHC Class II-dependent responses Galinpepimut-S is administered with the adjuvant Montanide and sargramostim GM-CSF
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 with immunomodulatory drugs IMIDs eg thalidomide lenalidomide or proteasome inhibitors PSIs eg bortezomib is allowed from 3 months after transplant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None