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 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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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 |
PRIMARY OBJECTIVES:
- 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
- To determine the feasibility and safety of this approach
SECONDARY OBJECTIVES:
- 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.
- To compare post-transplant recovery of T-regs and MDSCs between the two arms.
- To compare progression free survival (PFS) at 2 years post-transplant
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, 2022 |
Estimated Study Completion Date : | October 1, 2022 |

Arm | Intervention/treatment |
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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.
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Drug: Melphalan
Given IV
Other Names:
Procedure: Peripheral Blood Stem Cell Transplantation--CD34 HSCT Undergo autologous CD34 HSCT
Other Names:
Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT Undergo AHSCT
Other Names:
Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation Undergo autologous CD34 HSCT Biological: Tetanus Toxoid Vaccine Given IM
Other Names:
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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.
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Drug: Melphalan
Given IV
Other Names:
Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT Undergo AHSCT
Other Names:
Biological: Tetanus Toxoid Vaccine Given IM
Other Names:
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- 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
- 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.

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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 |
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.

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
Contact: Muhamed Baljevic, MD | 402-559-8562 | muhamed.baljevic@unmc.edu | |
Contact: Amberley Proctor, RN | 402-836-9171 |
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 |
Principal Investigator: | Muhamed Baljevic, MD | University of Nebraska |
Responsible Party: | Christopher Dangelo, 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 29, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |