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

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ClinicalTrials.gov Identifier: NCT02700841
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Muhamed Baljevic, MD, University of Nebraska

Brief 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.

Condition or disease Intervention/treatment Phase
Plasma Cell Myeloma Drug: Melphalan Procedure: Peripheral Blood Stem Cell Transplantation--CD34 HSCT Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation Biological: Tetanus Toxoid Vaccine Phase 2

Detailed 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, γδ 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation
Actual Study Start Date : May 2016
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

Arm Intervention/treatment
Experimental: Arm I (vaccine, CD34 transplant, DLI)
ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant.
Drug: Melphalan
Given IV
Other Names:
  • Alkeran
  • L-PAM
  • L-Phenylalanine Mustard
  • Phenylalanine Mustard
  • Sarcolysin

Procedure: Peripheral Blood Stem Cell Transplantation--CD34 HSCT
Undergo autologous CD34 HSCT
Other Names:
  • PBPC Transplantation
  • Peripheral Blood Progenitor Cell Transplantation
  • Peripheral Stem Cell Support
  • Peripheral Stem Cell Transplantation

Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT
Undergo AHSCT
Other Names:
  • PBPC transplantation
  • Peripheral Blood Progenitor Cell Transplantation
  • Peripheral Stem Cell Support
  • Peripheral Stem Cell Transplantation

Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation
Undergo autologous CD34 HSCT

Biological: Tetanus Toxoid Vaccine
Given IM
Other Names:
  • Tetanus Toxoid
  • TT

Active Comparator: Arm II (vaccine, stem cell transplant)
Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0.
Drug: Melphalan
Given IV
Other Names:
  • Alkeran
  • L-PAM
  • L-Phenylalanine Mustard
  • Phenylalanine Mustard
  • Sarcolysin

Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT
Undergo AHSCT
Other Names:
  • PBPC transplantation
  • Peripheral Blood Progenitor Cell Transplantation
  • Peripheral Stem Cell Support
  • Peripheral Stem Cell Transplantation

Biological: Tetanus Toxoid Vaccine
Given IM
Other Names:
  • Tetanus Toxoid
  • TT




Primary Outcome Measures :
  1. Number of safely treated patients (feasibility and safety) [ Time Frame: Baseline to 180 days post-transplant ]
    Determine safety of outcomes by CTCAE version 5.0 tool


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to 2 years post-transplant ]
    Kaplan Meier method, Logrank test, and Cox model will be employed to investigate the effect of ALC, AMC, and immune cells on survival post AHSCT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 19 years to 70 years old at time of study entry (consent)
  2. Diagnosis of Multiple Myeloma as per updated International Myeloma Working Group (IMWG) criteria .
  3. 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%.
  4. Must have standard risk myeloma (see exclusion criterion 4).
  5. 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)
  6. Able to understand and sign a consent form.
  7. Creatinine clearance equal or > 60 ml/min (calculated)
  8. 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.
  9. Serum bilirubin, ALT, AST less than 3 X upper limit of normal
  10. FVC, FEV1 or DLCO >50% predicted before admission for transplant as per institutional standards. Patients on home oxygen are not allowed on the protocol.
  11. No more than 6 months of pre-transplant MM chemotherapy is allowed (from the date of the start of the induction therapy).
  12. KPS ≥ 70%or ECOG 0-2.
  13. Must be eligible to receive Melphalan dose of 200mg/m2
  14. 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:

  1. Participation in another clinical study with an investigational product during the last 28 days.
  2. Prior stem cell transplant (either autologous or allogeneic)
  3. Creatinine clearance < 60 ml/min (calculated)
  4. 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.
  5. Documented central nervous system or extramedullary disease.
  6. Significant organ dysfunction deemed to carry inappropriate risk for AHSCT.
  7. Intention or plans for cyclophosphamide mobilization.
  8. Known allergic reactions after previous tetanus diphtheria vaccination or had a condition of Guillain Barre Syndrome (GBS)
  9. Known active hepatitis B, C or HIV infections on initial assessment.
  10. Enrollment on any other transplant related protocols.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700841


Contacts
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Contact: Muhamed Baljevic, MD 402-559-8562 muhamed.baljevic@unmc.edu
Contact: Amberley Proctor, RN 402-836-9171

Locations
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United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Amberley Nurse Coordinator    402-836-9171      
Contact: Christian Project Coordinator    4025595524      
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Muhamed Baljevic, MD University of Nebraska
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Responsible Party: Muhamed Baljevic, MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02700841    
Other Study ID Numbers: 669-19
NCI-2015-00743 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Mechlorethamine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs