Kahler disease Multiple myeloma
Conditions
Interventions
Patients monocytes will collected by apheresis. Patients will be vaccinated
intravenous and intradermal at 3 occasions with 2 weeks interval. Monitoring
will be done for toxicity, immune response an
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: · 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
Exclusion criteria
Exclusion criteria: · 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In vivo immune response to the tumor associated antigen epitopes in at least 3 out of 10 patients will be considered as a positive result. No response to any of the antigens will be considered a negative result. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end-points are clinical responses a decrease of minimal residual disease by molecular monitoring (ASO-PCR). | — |
Countries
Netherlands
Outcome results
None listed