Phase IIa trial of PD-L1 peptide vaccination as monotherapy in high risk smoldering multiple myeloma

Department of Hematology, Herlev and Gentofte University Hospital0 个研究点目标入组 20 人开始时间: 2018年10月17日最近更新: 2021年3月17日

试验速览

暂无简介。

•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

•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

发起方

Department of Hematology, Herlev and Gentofte University Hospital