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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vax-DC/MM
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chonnam National University Hwasun HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vax-DC/MM

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events
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
The International Myeloma Working Group uniform criteria were used to assess the clinical response.
Progression free survival
Progression free survival was defined as the period from the start of treatment until the end follow-up or death from any cause.

Full Information

First Posted
September 17, 2014
Last Updated
September 24, 2014
Sponsor
Chonnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02248402
Brief Title
Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Acronym
Vax-DC/MM
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vax-DC/MM
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Vax-DC/MM
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Clinical response after completion of Vax-DC/MM injection
Description
The International Myeloma Working Group uniform criteria were used to assess the clinical response.
Time Frame
2 year
Title
Progression free survival
Description
Progression free survival was defined as the period from the start of treatment until the end follow-up or death from any cause.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-Hoon Jung, M.D
Phone
+82 61 379 7622
Email
shglory@hanmail.net
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanamdo
ZIP/Postal Code
519-763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Hoon Jung, M.D
Phone
+82 61 379 7622
Email
shglory@hanmail.net
First Name & Middle Initial & Last Name & Degree
Sung-Hoon Jung, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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