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NCT02700841 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2024-03-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Safely Treated Participants (Feasibility and Safety)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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.
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant.
    intervention Names
    1. Drug: Melphalan
    2. Procedure: Peripheral Blood Stem Cell Transplantation--CD34 HSCT
    3. Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT
    4. Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation
    5. Biological: Tetanus Toxoid Vaccine
    label
    Arm I (vaccine, CD34 transplant, DLI)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Melphalan
    2. Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT
    3. Biological: Tetanus Toxoid Vaccine
    label
    Arm II (vaccine, stem cell transplant)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (vaccine, CD34 transplant, DLI)
    2. Arm II (vaccine, stem cell transplant)
    description
    Given IV
    name
    Melphalan
    other Names
    1. Alkeran
    2. L-PAM
    3. L-Phenylalanine Mustard
    4. Phenylalanine Mustard
    5. Sarcolysin
    type
    DRUG
  2. arm Group Labels
    1. Arm I (vaccine, CD34 transplant, DLI)
    description
    Undergo autologous CD34 HSCT
    name
    Peripheral Blood Stem Cell Transplantation--CD34 HSCT
    other Names
    1. PBPC Transplantation
    2. Peripheral Blood Progenitor Cell Transplantation
    3. Peripheral Stem Cell Support
    4. Peripheral Stem Cell Transplantation
    type
    PROCEDURE
  3. arm Group Labels
    1. Arm I (vaccine, CD34 transplant, DLI)
    2. Arm II (vaccine, stem cell transplant)
    description
    Undergo AHSCT
    name
    Peripheral Blood Stem Cell Transplantation--AHSCT
    other Names
    1. PBPC transplantation
    2. Peripheral Blood Progenitor Cell Transplantation
    3. Peripheral Stem Cell Support
    4. Peripheral Stem Cell Transplantation
    type
    PROCEDURE
  4. arm Group Labels
    1. Arm I (vaccine, CD34 transplant, DLI)
    description
    Undergo autologous CD34 HSCT
    name
    T Cell-Depleted Hematopoietic Stem Cell Transplantation
    type
    BIOLOGICAL
  5. arm Group Labels
    1. Arm I (vaccine, CD34 transplant, DLI)
    2. Arm II (vaccine, stem cell transplant)
    description
    Given IM
    name
    Tetanus Toxoid Vaccine
    other Names
    1. Tetanus Toxoid
    2. TT
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
8
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Determine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool
    measure
    Number of Safely Treated Participants (Feasibility and Safety)
    time Frame
    Through 180 days post-transplant
Full study description
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.
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
Source references
Source notices and limitations
    Discovery and provenance
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      payload
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      true
      id
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      nct id
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      occurrences
      1. context exact
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        end
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        exact text
        NCT02700841
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice