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Trial record 1 of 1 for:    VAX-DC/MM
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Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma (Vax-DC/MM)

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ClinicalTrials.gov Identifier: NCT02248402
Recruitment Status : Unknown
Verified September 2014 by Sung-Hoon Jung, Chonnam National University Hospital.
Recruitment status was:  Recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Sung-Hoon Jung, Chonnam National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Vax-DC/MM Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vax-DC/MM Biological: Vax-DC/MM



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 1 years ]
    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


Secondary Outcome Measures :
  1. Clinical response after completion of Vax-DC/MM injection [ Time Frame: 2 year ]
    The International Myeloma Working Group uniform criteria were used to assess the clinical response.

  2. Progression free survival [ Time Frame: 2 year ]
    Progression free survival was defined as the period from the start of treatment until the end follow-up or death from any cause.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248402


Contacts
Contact: Sung-Hoon Jung, M.D +82 61 379 7622 shglory@hanmail.net

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeollanamdo, Korea, Republic of, 519-763
Contact: Sung-Hoon Jung, M.D    +82 61 379 7622    shglory@hanmail.net   
Principal Investigator: Sung-Hoon Jung, M.D         
Sponsors and Collaborators
Chonnam National University Hospital

Responsible Party: Sung-Hoon Jung, M.D, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT02248402     History of Changes
Other Study ID Numbers: 13-038
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases