drugset / Trial / NCT02728102

Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

NCT02728102

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is designed as a Phase II, multicenter trial of vaccination with Dendritic cell/myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF following autologous transplant as part of upfront treatment of multiple myeloma (MM). It is hypothesized that the dendritic cell myeloma vaccine will result in improved response in patients with multiple myeloma after autologous Hematopoietic Cell Transplant (HCT).

Timeline

Start
2016-07
Primary completion
2020-06-30
Completion
2022-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Dendritic Cell Fusion Vaccine Vaccine 3e+06 cells Subcutaneous
Subject sargramostim Protein / enzyme biologic 100 ug Subcutaneous
Background Lenalidomide Other / unclassified 10 mg
Background Melphalan Small molecule 200 mg/m2

Indications