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

NCT02700841 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-03-12

Study results available
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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.

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

Melphalan

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation--CD34 HSCT

Undergo autologous CD34 HSCT

PROCEDURE

Peripheral Blood Stem Cell Transplantation--AHSCT

Undergo AHSCT

BIOLOGICAL

T Cell-Depleted Hematopoietic Stem Cell Transplantation

Undergo autologous CD34 HSCT

BIOLOGICAL

Tetanus Toxoid Vaccine

Given IM

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Christopher D'Angelo, MD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2022-12-21
Completion
2022-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700841 on ClinicalTrials.gov