We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    VAX-DC/MM
Previous Study | Return to List | Next Study

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Sung-Hoon Jung, Chonnam National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02248402
First Posted: September 25, 2014
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sung-Hoon Jung, Chonnam National University Hospital
  Purpose
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 Intervention Phase
Multiple Myeloma Biological: Vax-DC/MM Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sung-Hoon Jung, Chonnam National University Hospital:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 15
Study Start Date: October 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vax-DC/MM Biological: Vax-DC/MM

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: September 17, 2014
First Posted: September 25, 2014
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