CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 20
Inclusion Criteria
- Deemed eligible for ASCT by standard institutional criteria.
- Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
- Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.
- ...
- Deemed eligible for ASCT by standard institutional criteria.
- Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
- Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.
- Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.
- Age ≥18 years.
Exclusion Criteria
- 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.
- 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.
- History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
- Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.
- Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.
- Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT1.
- Prior autologous or allogeneic SCT.
Summary
- Conditions
- Multiple Myeloma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Deemed eligible for ASCT by standard institutional criteria.
- Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
- Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.
- ...
- Deemed eligible for ASCT by standard institutional criteria.
- Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
- Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.
- Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.
- Age ≥18 years.
Exclusion Criteria
- 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.
- 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.
- History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
- Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.
- Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.
- Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT1.
- Prior autologous or allogeneic SCT.
Tracking Information
- NCT #
- NCT01995708
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Chung, MD, PhD Memorial Sloan Kettering Cancer Center
- David Chung, MD, PhD Memorial Sloan Kettering Cancer Center
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