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

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    26
  • sponsor
    University of Nebraska
Updated on 26 January 2022
cyclophosphamide
filgrastim
ejection fraction
monoclonal antibodies
granulocyte colony stimulating factor
melphalan
measurable disease
cell transplantation
bone marrow procedure
induction therapy
dexamethasone
lenalidomide
colony stimulating factor
chemotherapy regimen
bortezomib
monoclonal protein

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.

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, 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

Details
Condition Plasma Cell Myeloma
Treatment melphalan, therapeutic autologous lymphocytes, Peripheral Blood Stem Cell Transplantation--CD34 HSCT, Peripheral Blood Stem Cell Transplantation--AHSCT, T Cell-Depleted Hematopoietic Stem Cell Transplantation, Tetanus Toxoid Vaccine, Trivalent Influenza Vaccine, XBP1-US/XBP1-SP/CD138/CS1 Multipeptide Vaccine PVX-410
Clinical Study IdentifierNCT02700841
SponsorUniversity of Nebraska
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 19 years to 70 years old at time of study entry (consent)
Diagnosis of Multiple Myeloma as per updated International Myeloma Working Group (IMWG) criteria
Must have measurable disease defined as: for secretory MM, serum monoclonal protein 1.0 g/dL, urine monoclonal protein 200 mg/24 hrs, and involved free light chain 10 mg/dL; or in case of non-secretory MM, bone marrow plasma cell percentage 30%
Must have standard risk myeloma (see exclusion criterion 4)
Must have received bortezomib, lenalidomide and dexamethasone (VRd) as a form of induction therapy pre-AHSCT (use of cyclophosphamide, bortezomib and dexamethasone may be allowed for up to 2 weekly doses before initiation of VRd induction, if necessary clinically for cytoreduction)
Able to understand and sign a consent form
Creatinine clearance equal or > 60 ml/min (calculated)
Ejection fraction equal or > 50% before admission for transplant as per institutional standards. 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 institutional BMT standards
Serum bilirubin, ALT, AST less than 3 X upper limit of normal
FVC, FEV1 or DLCO >50% predicted before admission for transplant as per institutional standards. Patients on home oxygen are not allowed on the protocol
No more than 6 months of pre-transplant MM chemotherapy is allowed (from the date of the start of the induction therapy)
KPS 70%or ECOG 0-2
Must be eligible to receive Melphalan dose of 200mg/m2
A female of child-bearing potential, must have two negative urine pregnancy test results within 10 to 14 days prior to starting the first dose of vaccine pre-transplant as a way of ensuring safe transplant planning

Exclusion Criteria

Participation in another clinical study with an investigational product during the last 28 days
Prior stem cell transplant (either autologous or allogeneic)
Creatinine clearance < 60 ml/min (calculated)
High risk MM defined as those with the following disease, fluorescence in situ hybridization and/or cytogenetic features: del17p, del1p with 1q gain, t(4;14), t(14;16), t(14;20), >1 cytogenetic abnormality on karyotype, hypodiploid, plasma cell leukemia (primary or secondary), or subjects who failed to achieve PR to induction therapy (i.e. VRd) and required salvage induction prior to AHSCT
Documented central nervous system or extramedullary disease
Significant organ dysfunction deemed to carry inappropriate risk for AHSCT
Intention or plans for cyclophosphamide mobilization
Known allergic reactions after previous tetanus diphtheria vaccination or had a condition of Guillain Barre Syndrome (GBS)
Known active hepatitis B, C or HIV infections on initial assessment
Enrollment on any other transplant related protocols
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