Phase
Condition
Multiple Myeloma
Bone Neoplasm
Leukemia
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Relapsed or refractory multiple myeloma who received at least one prior therapyincluding thalidomide, bortezomib, or lenalidomide-containing regimen
Subjects with measurable disease defined as at least one of the following SerumM-protein ≥ 1.0 g/dL Urine M-protein ≥ 400 mg/24hr
Eastern Cooperative Oncology Group Performance Status ≤ 2
Hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L): Prior red blood cell transfusion or recombinanthuman erythropoietin use is allowed.
Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
Aspartate aminotransferase (AST) < 3 times the upper limit of normal
Alanine aminotransferase (ALT) < 3 times the upper limit of normal
Subjects (or their legally acceptable representatives) must have signed an informedconsent document indicating that they understand the purpose of and proceduresrequired for the study and are willing to participate in the study
Exclusion
Exclusion Criteria:
Smoldering or indolent myeloma
Uncontrolled or severe cardiovascular disease (cardiac ejection fraction<0.5, Severeconduction disorder )
Sepsis or current active infection
Pregnancy or breastfeeding
Received other immunotherapy treatment
Clinically significant autoimmune disease
Serious medical or psychiatric illness likely to interfere with participation in thisclinical study
Study Design
Study Description
Connect with a study center
Chonnam National University Hwasun Hospital
Hwasun, Jeollanamdo 519-763
Korea, Republic ofActive - Recruiting

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