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

Last updated: September 24, 2014
Sponsor: Chonnam National University Hospital
Overall Status: Trial Status Unknown

Phase

1/2

Condition

Multiple Myeloma

Bone Neoplasm

Leukemia

Treatment

N/A

Clinical Study ID

NCT02248402
13-038
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Relapsed or refractory multiple myeloma who received at least one prior therapyincluding thalidomide, bortezomib, or lenalidomide-containing regimen

  • Subjects with measurable disease defined as at least one of the following SerumM-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 recombinanthuman 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 informedconsent document indicating that they understand the purpose of and proceduresrequired for the study and are willing to participate in the study

Exclusion

Exclusion Criteria:

  • Smoldering or indolent myeloma

  • Uncontrolled or severe cardiovascular disease (cardiac ejection fraction<0.5, Severeconduction 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 thisclinical study

Study Design

Total Participants: 15
Study Start date:
October 01, 2013
Estimated Completion Date:

Study 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.

Connect with a study center

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanamdo 519-763
    Korea, Republic of

    Active - Recruiting

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