Finding studies
Finding studies
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Lead
Case Comprehensive Cancer Center
The overall objective of this pilot study is to determine the safety and preliminary efficacy of a dendritic cell DKK1 vaccine in view of possible future use as a strategy to prevent progression of asymptomatic plasma cell disorders, maintain disease control, and ultimately contribute to eradication of multiple myeloma, light and heavy chain amyloidosis, immunoglobulin deposition disease, and other malignant and non-malignant diseases related to transformed plasma cells. Primary Objective Confirm the safety of dendritic cell DKK1 vaccine given every two weeks for three doses in patients with monoclonal gammopathy, stable or smoldering myeloma. Secondary Objectives 1. Assess response according to international response criteria (\> partial response, PR) and clinical benefit response (\>minor response, MR, according to adapted EBMT criteria) 2. Determine time to progression 3. Describe progression-free and overall survival Correlative Objectives 1. Explore correlation between myeloma DKK1 and PDL-1 expression and response 2. Determine cellular immune response 3. Assess serologic anti-DKK1 antibody response Study design including dose escalation / cohorts Pilot study with 3 patient safety run-in, possible dose level -1 (DL-1) if dose limiting toxicity occurs in one or more patients at the target dose level, and, at the first dose level where no dose limiting toxicity occurs, extension by 12 patients. DLT will be defined as any vaccine related toxicity \> grade 3 that does not resolve to grade \< 2 within 7 days. If any DLT occurs at DL-1 enrollment will be stopped and an amendment will be discussed.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
