Plasma Cell MyelomaPhase 2NCT02700841
Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation
A Phase 2 study testing Melphalan, Peripheral Blood Stem Cell Transplantation--CD34 HSCT and Peripheral Blood Stem Cell Transplantation--AHSCT in people with Plasma Cell Myeloma, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Melphalan, Peripheral Blood Stem Cell Transplantation--CD34 HSCT and Peripheral Blood Stem Cell Transplantation--AHSCT
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 21 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation
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.
Read the detailed description
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
- Conditions
- Plasma Cell Myeloma
- Being tested
- Melphalan, Peripheral Blood Stem Cell Transplantation--CD34 HSCT, Peripheral Blood Stem Cell Transplantation--AHSCT, T Cell-Depleted Hematopoietic Stem Cell Transplantation, Tetanus Toxoid Vaccine
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Alkeran, L-PAM, L-Phenylalanine Mustard, Phenylalanine Mustard
Given IV
Peripheral Blood Stem Cell Transplantation--CD34 HSCTProcedure or surgery
Also called PBPC Transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation
Undergo autologous CD34 HSCT
Peripheral Blood Stem Cell Transplantation--AHSCTProcedure or surgery
Also called PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation
Undergo AHSCT
T Cell-Depleted Hematopoietic Stem Cell TransplantationBiological
Undergo autologous CD34 HSCT
Tetanus Toxoid VaccineBiological
Also called Tetanus Toxoid, TT
Given IM
| Study group | Role | What they receive |
|---|---|---|
| Arm I (vaccine, CD34 transplant, DLI) | Experimental | ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant. Receives: 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 |
| Arm II (vaccine, stem cell transplant) | Active comparator | 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. Receives: Drug: Melphalan; Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT; Biological: Tetanus Toxoid Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Safely Treated Participants (Feasibility and Safety)
Determine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool
Measured: Through 180 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start9 Jan 2020
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Why it stopped: Study terminated prematurely due to poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher D'Angelo, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700841
- Sponsor's protocol ID
- 0669-19-FB
- Other IDs
- NCI-2015-00743
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2016
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02700841
- Acronym / sponsor ID
- 0669-19-FB
- Conditions
- Plasma Cell Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to poor recruitment.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (vaccine, CD34 transplant, DLI) | Experimental | 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 VaccineARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant. |
| Arm II (vaccine, stem cell transplant) | Active comparator | Drug: Melphalan, Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT, Biological: Tetanus Toxoid VaccinePatients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelphalanAlso: Alkeran, L-PAM, L-Phenylalanine Mustard, Phenylalanine MustardGiven IV | Drug | Arm I (vaccine, CD34 transplant, DLI), Arm II (vaccine, stem cell transplant) |
| Peripheral Blood Stem Cell Transplantation--CD34 HSCTAlso: PBPC Transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell TransplantationUndergo autologous CD34 HSCT | Procedure or surgery | Arm I (vaccine, CD34 transplant, DLI) |
| Peripheral Blood Stem Cell Transplantation--AHSCTAlso: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell TransplantationUndergo AHSCT | Procedure or surgery | Arm I (vaccine, CD34 transplant, DLI), Arm II (vaccine, stem cell transplant) |
| T Cell-Depleted Hematopoietic Stem Cell TransplantationUndergo autologous CD34 HSCT | Biological | Arm I (vaccine, CD34 transplant, DLI) |
| Tetanus Toxoid VaccineAlso: Tetanus Toxoid, TTGiven IM | Biological | Arm I (vaccine, CD34 transplant, DLI), Arm II (vaccine, stem cell transplant) |
Primary outcome
Number of Safely Treated Participants (Feasibility and Safety)
Time frame: Through 180 days post-transplant
Determine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D'Angelo, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melphalan, Peripheral Blood Stem Cell Transplantation--CD34 HSCT and Peripheral Blood Stem Cell Transplantation--AHSCT in people with Plasma Cell Myeloma, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Safely Treated Participants (Feasibility and Safety) (time frame: Through 180 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.