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 potent immunotherapeutic agent generated by dendritic cells loaded with the ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this study is to examine the safety and efficacy of Vax-DC/MM in patients with relapsed or refractory multiple myeloma.
* 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 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Chonnam National University Hwasun Hospital
Hwasun, Jeollanamdo, South Korea
RECRUITINGNumber of participants with adverse events
Adverse events were assessed using the National Cancer Institute common toxicity criteria (NCI-CTC) for adverse events version 4.0 every injection of Vax-DC/MM
Time frame: 1 years
Clinical response after completion of Vax-DC/MM injection
The International Myeloma Working Group uniform criteria were used to assess the clinical response.
Time frame: 2 year
Progression free survival
Progression free survival was defined as the period from the start of treatment until the end follow-up or death from any cause.
Time frame: 2 year
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