Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation

Plasma Cell Myeloma Clinical Trial

Official title: A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation

Status Terminated

Clinical Trial Summary

This pilot randomized Phase II trial (10 subjects per arm) will compare immune reconstitution following transplantation of an autologous mobilized graft product to reconstitution following transplantation of a mobilized graft product followed by an autologous lymphocyte infusion collected prior to G-CSF mobilization. All subjects will receive tetanus vaccines pre and post-transplant. The primary end point will be tetanus vaccine immune responses post-transplant.

Clinical Trial Description

PRIMARY OBJECTIVES:

1. To compare the cellular and humoral vaccine response post-transplant between the two arms by performing Elisa, and T-cell enzyme-linked immunospot (ELISPOT) assays

2. To determine the feasibility and safety of this approach

SECONDARY OBJECTIVES:

1. To compare post-transplant recovery of innate and adaptive immune cells (CD8, CD4, CD19, NK, γδ T-cells), in addition to T-cell phenotype markers between the two arms.

2. To compare post-transplant recovery of T-regs and MDSCs between the two arms.

3. To compare progression free survival (PFS) at 2 years post-transplant ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma
• Tetanus

• NCT number: NCT02700841
• Study type: Interventional
• Source: University of Nebraska
• Status: Terminated
• Phase: Phase 2
• Start date: January 9, 2020
• Completion date: December 21, 2022