NCT01995708CompletedPhase 1
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
Memorial Sloan Kettering Cancer Center1 site in 1 country28 target enrollmentStarted: January 31, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Number of Participants Evaluated for Vaccine Safety
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 WT
- •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.
Outcomes
Primary Outcomes
Number of Participants Evaluated for Vaccine Safety
Time Frame: 1 year
Participants will be evaluated for the safety of the vaccine, 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. The only toxicities captured outside of the SAEs reported will be all grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study.
Secondary Outcomes
- Median Progression Free Survival(Up to 7 years)
Investigators
Study Sites (1)
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LymphomaStage I Adult Lymphoblastic LymphomaStage I Adult T-cell Leukemia/LymphomaStage I Chronic Lymphocytic LeukemiaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Grade 3 Follicular LymphomaStage I Mantle Cell LymphomaStage I Multiple MyelomaStage I Small Lymphocytic LymphomaStage IA Mycosis Fungoides/Sezary SyndromeStage IB Mycosis Fungoides/Sezary SyndromeStage II Adult Hodgkin LymphomaStage II Adult T-cell Leukemia/LymphomaStage II Chronic Lymphocytic LeukemiaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Multiple MyelomaStage IIA Mycosis Fungoides/Sezary SyndromeStage IIB Mycosis Fungoides/Sezary SyndromeStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Hodgkin LymphomaStage III Adult Lymphoblastic LymphomaStage III Adult T-cell Leukemia/LymphomaStage III Chronic Lymphocytic LeukemiaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Grade 1 Follicular 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