Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT02248402
Last Updated: 2014-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2013-10-31
Brief Summary
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Detailed Description
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* Not everyone who participants in this study will be receiving the same dose of study vaccine. A small group of patients will be enrolled into the study and given a certain dose. If they tolerate it, the next group of patients enrolled will received a higher dose.
* Before the first injection of Vax-DC, low dose cyclophosphamide will be administered to stimulate immune response.
* Participants will be received a certain dose of Vax-DC weekly four times.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vax-DC/MM
Vax-DC/MM
Interventions
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Vax-DC/MM
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Chonnam National University Hospital
OTHER
Responsible Party
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Sung-Hoon Jung
M.D
Locations
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Chonnam National University Hwasun Hospital
Hwasun, Jeollanamdo, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13-038
Identifier Type: -
Identifier Source: org_study_id
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