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

Overview

This pilot randomized Phase II trial (10 patients 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.

SparkCures ID 798
Trial Phase Phase 2
Enrollment 26 Patients
Treatments
Tags
Trial Sponsors
  • Winship Cancer Institute of Emory University
Trial Collaborators
  • OncoPep, Inc.
NCT Identifier

NCT02700841

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Diagnosis of multiple myeloma
  • The first 3 patients on the experimental arm will be high risk myeloma and subsequent patients will be low risk myeloma; high risk multiple myeloma patient who have: deletion (del) 17p, del 1p, T (4;14), T (14;16), plasma cell leukemia (PCL), > 1 cytogenetic abnormality
  • Able to understand and sign a consent form
  • Creatinine clearance equal or > 50 ml/min (calculated)
  • Ejection fraction equal or > 50%; patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months or arrhythmia) need to be cleared by cardiology as per Emory bone marrow transplant (BMT) standards
  • Serum bilirubin less than 3 X upper limit of normal
  • Alanine aminotransferase (ALT) less than 3 X upper limit of normal, aspartate aminotransferase (AST) less than 3 X upper limit of normal
  • Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted; patients on home oxygen are not allowed on the protocol
  • No more than six months' worth of multiple myeloma chemotherapy is allowed (from the date of the start of the induction therapy)
  • Karnofsky performance status (KPS) ≥ 70%
  • Patient's must be eligible to receive melphalan dose of 200 mg/m²
  • Patients must be human leukocyte antigen (HLA) A2 positive by polymerase chain reaction (PCR) typing

Exclusion Criteria:

  • Patient with a prior stem cell transplant (both autologous and allogeneic)
  • Creatinine clearance < 50 ml/min (calculated)
  • Patients with documented central nervous system (CNS) disease
  • Significant organ dysfunction deemed to be inappropriate for autologous transplantation
  • Intention or plans for cyclophosphamide mobilization
  • Patients with active hepatitis B, C or human immunodeficiency virus (HIV) infections (PCR positive)
  • Enrollment on any other transplant related protocols
  • Pregnant women are excluded from participating in this study; collect urine for pregnancy test for female patients who are not postmenopausal or surgically sterile which is part of standard of care. If positive, repeat and confirm results prior to visit 2; a second positive test will result in exclusion of the patient from the study

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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