drugset / Trial / NCT01827137

WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation

NCT01827137

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-04
Primary completion
2016-12-07
Completion
2017-11-06

Publications

  • Results Koehne G, Devlin S, Korde N, Mailankody S, Landau H, Hassoun H, Lesokhin A, Lendvai N, Chung D, Sarlis N, Giralt S, Landgren O. Galinpepimut-S, a WT1-Targeting Immuno-Oncology Treatment, Induces Specific, Robust and Durable Immune Responses (IRs) in Patients (Pts) with High-Risk (HR) Multiple Myeloma (MM). Clinical Lymphoma, Myeloma and Leukemia 17: S343-S344, 2017

Drugs

EvaluationDrugModalityDoseRoute
Subject Galinpepimut-S Vaccine Subcutaneous
Background Bortezomib Small molecule
Background Lenalidomide Other / unclassified
Background sargramostim Protein / enzyme biologic 70 ug Subcutaneous

Indications