CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Rockefeller University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01995708
First received: November 20, 2013
Last updated: June 17, 2014
Last verified: June 2014

November 20, 2013
June 17, 2014
November 2013
November 2015   (final data collection date for primary outcome measure)
safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The safety of the vaccine will be monitored and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for toxicity and adverse event reporting to the Food and Drug Administration. Dose limiting toxicity (DLT) is defined as grade 3 or higher toxicity.
Same as current
Complete list of historical versions of study NCT01995708 on ClinicalTrials.gov Archive Site
Immune response monitoring [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The secondary goal of the study is to monitor and compare changes in T cell responses (e.g., intracellular cytokine secretion assays, CTL responses, and immune reconstitution analyses) stimulated by the CT7, MAGE-A3, and WT1 mRNA-electroporated LCs relative to pre-vaccine baselines.
Same as current
Not Provided
Not Provided
 
CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
A Phase I Trial of Vaccination With CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Biological: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)
    Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant.
  • Other: Standard of care
    No vaccines
  • Experimental: Arm 1 Vaccine
    This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical & Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10^6 LCs per dose (i.e., combination of 3x10^6 CT7 mRNA-electroporated LCs + 3x10^6 MAGE-A3 mRNA-electroporated LCs + 3x10^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression.
    Intervention: Biological: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)
  • Active Comparator: Arm 2 control
    Patients receive standard of care treatment after autologous stem cell transplant
    Intervention: Other: Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: David Chung, MD PhD 212-639-6617
Contact: James Young, MD 646-888-2052
United States
 
NCT01995708
13-009
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Rockefeller University
Principal Investigator: David Chung, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP