NCT02248402

Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2a Study to Evaluate Safety and Efficacy of Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

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 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

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Vax-DC/MM

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-10-01
• First posted: 2014-09-25
• Last updated: 2014-09-25

Locations

1 site across 1 country: South Korea