Vaccination against PD-L1 for patients with smoldering multiple myeloma

Phase 1

• Conditions: High risk smoldering multiple myeloma.; MedDRA version: 20.0Level: LLTClassification code 10075894Term: Smoldering myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003990-93-DK
• Lead Sponsor: Department of Hematology, Herlev and Gentofte University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Age =18 years
•Smoldering multiple myeloma diagnosed < 5 years prior to inclusion
•Performance status = 2 (ECOG-scale)
•High risk of progression to symptomatic multiple myeloma defined by the Revised 2018 Mayo Criteria”1:
o= 2 of the risk factors below:
?Bone marrow Plasma Cells (BMPCs) = 20%
?M-component > 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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified