Status:
UNKNOWN
Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Chonnam National University Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma. Vax-DC/MM is an...
Detailed Description
* To create the Vax-DC/MM, myeloma cells will be obtained from the bone marrow of the participants, and leukapheresis will be performed to obtain dendritic cells * Not everyone who participants in thi...
Eligibility Criteria
Inclusion
- Relapsed or refractory multiple myeloma who received at least one prior therapy including thalidomide, bortezomib, or lenalidomide-containing regimen
- Subjects with measurable disease defined as at least one of the following Serum M-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 recombinant human 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 informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion
- Smoldering or indolent myeloma
- Uncontrolled or severe cardiovascular disease (cardiac ejection fraction\<0.5, Severe conduction 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 this clinical study
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02248402
Start Date
October 1 2013
Last Update
September 25 2014
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun, Jeollanamdo, South Korea, 519-763