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

Multiple Myeloma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02248402
• Other study ID #: 13-038
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 17, 2014
• Last updated: September 24, 2014
• Start date: October 2013

Study information

• Verified date: September 2014
• Source: Chonnam National University Hospital
• Contact: Sung-Hoon Jung, M.D
• Phone: +82 61 379 7622
• Email: shglory[@]hanmail.net
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• Vax-DC/MM

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanamdo

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 years	Yes
Secondary	Clinical response after completion of Vax-DC/MM injection	The International Myeloma Working Group uniform criteria were used to assess the clinical response.	2 year	No
Secondary	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.	2 year	No