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Galinpepimut-S

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

Ensayo de SELLAS Life Sciences Group, Inc. en Mieloma multiple.

Más ensayos de: Mieloma múltiple.

Fase

Fase 1/2

Estado

Completado

Participantes

20

previstos

Centros

1

Fin del objetivo primario

dic 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2013.

Qué mide

WT1 T-cell Immune Response (IR) 12-14 Weeks After First GPS Administration (6 x Administrations) (12 weeks after the initial GPS vaccine (end of first series [GPS x 6 administrations])) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de SLS

Todos los de SLS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01827137), actualizada en sep 2024.