Vaccination of Multiple Myeloma patients with RNA electroporated mature dendritic cells expressing multiple tumor antigens.
- Conditions
- Kahler diseaseMultiple myeloma10035227
- Registration Number
- NL-OMON34526
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
· Age 18-70 years
· Patients with stage II and III MM
· Complete remission (CR) or partial response (PR) following intensive therapy, including high dose melphalan and autologous stem cell transplantation
· Measurable minimal residual disease by M-component (complete of light chain) or molecular disease by BM ig heavy chain rearrangement (ASO-PCR)
·Myeloma cells expressing 2-3 of the 3 TAA used for vaccination, each in >20% of CD138+CD38++ plasma cells
· Interval of >6 months after completion of intensive chemotherapy.
· Life expectancy >6 months
· Expected adequacy for follow-up including bone marrow evaluation
· Written Informed consent
· Progressive disease (increase in M-component of >25% in the last 3 months)
· Patients on immunosuppressive drugs
· Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
· Patients with known allergy to shell fish (contains KLH).
· Patients with pregnancy or lactation
· WHO performance status 4
· Allogeneic stem cell transplantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In vivo immune response to the tumor associated antigen epitopes in at least 3<br /><br>out of 10 patients will be considered as a positive result. No response to any<br /><br>of the antigens will be considered a negative result. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary end-points are clinical responses a decrease of minimal residual<br /><br>disease by molecular monitoring (ASO-PCR).</p><br>