High risk smoldering multiple myeloma. MedDRA version: 20.0 Level: LLT Classification code 10075894 Term: Smoldering myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: PD-L1 (Long1)
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Montanide ISA51
CAS Number: 190396-06-6
Other descriptive name: MONTANIDE ISA51
Concentrati
Sponsors
Department of Hematology, Herlev and Gentofte University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years • Smoldering multiple myeloma diagnosed 2g/dL ? Free light chain (FLC) ratio > 20 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Non-secretory myeloma • Other malignancies in the medical history excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer and patients cured for another malignant disease with no sign of relapse two years after ended treatment. • Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus. • Acute or chronic viral infection e.g. HIV, hepatitis or tuberculosis • Serious known allergies or earlier anaphylactic reactions. • Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. • Pregnant and breastfeeding women. • Patients taking immune suppressive medications incl. corticosteroids and methotrexate at the time of enrollment • Psychiatric disorders that per investigator judgment could influence compliance. • Treatment with other experimental drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the phase IIa trial is to investigate the rate of response in patients with high risk smoldering multiple myeloma vaccinated with PD-L1 long1.;Secondary Objective: Furthermore, immunogenicity of the vaccine, adverse events, quality of life, time to progression and overall survival will be described.;Primary end point(s): • Overall response rate (ORR);Timepoint(s) of evaluation of this end point: Three months after last vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Immunogenicity of the vaccine (blood and bone marrow) • Incidence of treatment emergent adverse events (TEAE) and patient reported outcomes (PRO) in terms of quality of life (QoL) as well as patient reported adverse events (PRO-CTCAE) • Progression-free survival (PFS) • Time to progression (TTP) • Overall survival (OS) ;Timepoint(s) of evaluation of this end point: Analysis of Immunogenicity, PRO and Adverse events will be performed when the latest enrolled patient has been followed three months after last given vaccine. Analysis of TTP, PFS and OS will be performed at two time points of 48 months and 5 years from the inclusion of the latest enrolled patient. | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Information
Center for Cancer Immune Therapy, Department of Hematology, Herlev and Gentofte University Hospital
Outcome results
None listed