Multiple Myeloma Clinical Trial
Official title:
A Phase 1/2a Study to Evaluate Safety and Efficacy of Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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