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

NCT02248402 | Unknown Phase 1 DMC

• 1 other identifier: 13-038
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Clinical response after completion of Vax-DC/MM injection

  2 year

• Progression free survival

  2 year

Study Arms (1)

Vax-DC/MM

EXPERIMENTAL

Biological: Vax-DC/MM

Interventions

Vax-DC/MM BIOLOGICAL

Vax-DC/MM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanamdo, 519-763, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Sung-Hoon Jung, M.D

CONTACT

+82 61 379 7622; shglory@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 25, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

KR (1)