NCT03850522

Brief Summary

This study is evaluating a new vaccine against PD-L1 as a possible treatment for high-risk smoldering multiple myeloma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

February 19, 2019

Last Update Submit

April 8, 2022

Conditions

Smoldering Multiple Myeloma

Keywords

smolderingmyelomavaccinationPD-L1high-risk

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    Overall response rates (ORR) defined by IMWG criteria as PR+VGPR+CR+sCR during treatment and two weeks after end of treatment per patient.

    Planned analysis cut-off per patient: two weeks after last vaccination.

Secondary Outcomes (5)

  • Immunogenicity of the PD-L1 vaccine

    Samples taken before, during and two weeks after last vaccination.

  • Incidence of Treatment Emergent Adverse Events

    Planned analysis cut-off per patient: two weeks after last vaccination

  • Progression-free survival (PFS)

    Planned analysis 2 years and 5 years post initiation of therapy.

  • Time to progression (TTP)

    Planned analysis 2 years and 5 years post initiation of therapy.

  • Overall survival (OS)

    Planned analysis 2 years and 5 years post initiation of therapy.

Other Outcomes (3)

  • Quality of Life (QoL)

    Baseline and up to two weeks after last vaccination

  • Quality of Life (QoL)

    Baseline and up to two weeks after last vaccination

  • Quality of Life (QoL)

    Baseline and up to two weeks after last vaccination

Study Arms (1)

Vaccination

EXPERIMENTAL

Vaccination with PD-L1 peptide

Biological: PD-L1 peptide

Interventions

PD-L1 peptideBIOLOGICAL

PD-L1 peptide (100 micrograms) emulsified with the adjuvant Montanide ISA-51 given subcutaneously 10 times every second week over the course of 26 weeks including a five-week break.

Also known as: IO103
Vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has confirmed SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition (International Working Group, 2003)
  • Serum M-component \>30g/L and/or
  • Urine M-component ≥ 500mg/24 hours and/or
  • ≥10% clonal plasma cells in bone marrow

You may not qualify if:

  • High risk of progression to symptomatic multiple myeloma defined by the presence of ≥ 2 of the risk factors below:
  • Bone marrow Plasma Cells (BMPCs) ≥ 20%
  • M-component \> 2g/dL
  • FLC ratio \> 20
  • Age ≥18 years
  • Performance status ≤ 2 (ECOG-scale)
  • Expected survival \> 3 months
  • Sufficient liver function, i.e.
  • ALAT \< 2.5 upper normal limit, i.e. ALAT \<112 U/l
  • Bilirubin \< 30 U/l
  • Women agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.
  • For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.
  • The accepted contraceptive methods are
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation. Oral, intravaginal or transdermal.
  • Progestogen-only hormonal contraception associated with inhibition of ovulation. Oral, injectable, implantable.
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Universityhospital Herlev and Gentofte

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Smoldering Multiple MyelomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsHypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesParaproteinemiasImmunoproliferative DisordersImmune System DiseasesNeoplasms by Histologic Type

Study Officials

  • Nicolai Jørgensen, MD

    Department of Hematology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department, Department of Hematology

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 21, 2019

Study Start

February 18, 2019

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

DK(1)