CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
CT7,, MAGE-A3, WT1 mRNA-electroporated Autologous Langerhans, vaccine, 13-009
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs) Type: Biological
Name: Standard of care Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to see if the investigator can help the immune system to work against myeloma.

This study will see if a vaccine made with altered dendritic cells will make T cells work against tumor cells. The stem cells collected for the transplant will also be used to grow dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then will be injected under the skin. The investigators will do lab studies before and after the vaccination to find out if the vaccine is working.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.

- Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.

- Deemed eligible for ASCT by standard institutional criteria.

- Age ≥18 years.

- Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.

Exclusion Criteria:

- Prior autologous or allogeneic SCT.

- Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT1.

- Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.

- History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.

- History of severe allergic reactions to vaccines or unknown allergens.

- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization.

- Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.
Locations
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: David Chung, MD, PhD - 212-639-6617
The Rockefeller University/Center for Clinical & Translational Science
New York, New York, United States
Status: Recruiting
Contact: David Chung, MD, PhD - 212-639-6617
Start Date
November 2013
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page