drugset / Trial / NCT02334865

SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy

NCT02334865

Phase 1 Active not recruiting 18 enrolled Roswell Park Cancer Institute Celgene Corporation · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant together with sargramostim in treating patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from survivin peptide may help the body build an effective immune response to kill cancer cells that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide maintenance therapy may be a better treatment for multiple myeloma.

Timeline

Start
2017-04-13
Primary completion
2022-09-16
Completion
2026-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified Oral
Subject SVN53-67/M57-KLH Peptide Vaccine Vaccine Subcutaneous
Background incomplete Freund's adjuvant Other / unclassified Subcutaneous
Background sargramostim Protein / enzyme biologic Subcutaneous

Indications