Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma (Vax-DC/MM)

Chonnam National University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Multiple Myeloma

Treatments

Biological: Vax-DC/MM

Study type

Interventional

Funder types

Other

Identifiers

NCT02248402

13-038

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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