Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma

Overview

Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may be an effective treatment for multiple myeloma.

This phase I trial is studying the side effects and best dose of vaccine therapy when given with or without cyclophosphamide in treating patients with recurrent or refractory multiple myeloma.

SparkCures ID 187
Trial Phase Phase 1/2
Enrollment 54 Patients
Treatments
Trial Sponsors
  • Mayo Clinic
Trial Collaborators
  • National Cancer Institute (NCI)
NCT Identifier

NCT00450814

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:

  • Relapsed or refractory myeloma that with evidence of progression on an immunomodulatory drug (IMiD), a proteasome inhibitor, and an alkylator; NOTE: progression within 1 year post-high-dose chemotherapy with autologous stem cell support would qualify as alkylator refractory
  • Absolute neutrophil count (ANC) >= 1000/uL
  • Platelets (PLT) >= 50,000/uL
  • Hemoglobin >= 8.5 g/dl
  • Aspartate aminotransferase (AST) =< 2 times upper limit of normal
  • Creatinine < 2 times upper limit of normal
  • Total bilirubin =< 1.5 x upper limit of normal
  • International normalized ratio (INR) =< 1.4 x ULN at the time of registration
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester for follow-up
  • Life expectancy >= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Willingness to provide all biological specimens as required by the protocol
  • Negative serum pregnancy test done =< 7 days prior to registration for women of childbearing potential only
  • Measles antibody titer on the BioRad Multiplex assay less than or equal to 0.3 and absence of measles neutralizing antibody by plaque reduction neutralization assay

Exclusion Criteria:

  • Uncontrolled infection
  • Active tuberculosis
  • Chemotherapy =< 3 weeks prior to study registration
  • Immunotherapy =< 4 weeks prior to study registration
  • Biologic therapy =< 4 weeks prior to study registration
  • New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
  • Active central nervous system (CNS) disorder or seizure disorder
  • Human immunodeficiency virus (HIV) positive test result
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation)
  • Previous exposure to heat inactivated measles virus vaccine (this vaccine was given to some individuals between the years of 1963-1967)
  • Any of the following:
    • Pregnant women or women of reproductive ability who are unwilling to use effective contraception
    • Nursing women
    • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
  • Evidence of chronic or acute graft versus host disease or on-going treatment for graft versus host disease from prior allogeneic stem cell transplantation
  • Exposure to household contacts =< 15 months old or household contact with known immunodeficiency

US Trial Locations

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

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