Enhancing Anti-Myeloma Vaccine Response After Autologous Stem Cell Transplantation

Overview

This pilot, randomized phase II trial studies how well depleted immune suppressor stem cell transplant works compared to standard stem cell transplant in enhancing immune response to vaccines in patients with multiple myeloma (MM).

Chemotherapy and the patient's own stem cells are effective in treating MM, however there is a risk of disease returning due to poor recovery of the immune system as shown to poor response to vaccines to prevent infections. Before chemotherapy, patients' stem cells are collected and certain immune cells called suppressor cells are removed from the stem cells. Patients then receive chemotherapy to kill cancer cells and after that the immune depleted stem cells are returned to them to replace the blood-forming cells that were destroyed by chemotherapy. Giving depleted immune suppressor stem cells transplant to patients with MM may result in a more robust immune response to vaccines after transplant and may prevent MM from returning. It is not yet known whether depleted immune suppressor stem cell transplant is more effective than standard stem cell transplant in enhancing immune response to vaccines in patients with multiple myeloma.

SparkCures ID 798
Trial Phase Phase 2
Enrollment 26 Patients
Treatments
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

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified Winship Cancer Institute of Emory University

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Georgia
Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more

Resources

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