Phase 1
Completed N=28
CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Source: ClinicalTrials.gov NCT01995708 ↗Enrolled (actual)
28
Serious AEs
17.9%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants Evaluated for Vaccine Safety — 13; 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Evaluated for Vaccine Safety |
13; 15 | — |
| SECONDARY Median Progression Free Survival |
31; 54 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01995708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.