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van CCT (UK)

van CCT (UK)

RNA-DC vaccination in multiple myeloma.

- candidate number2807
- NTR NumberNTR1086
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-okt-2007
- Secondary IDsPMM17 Trialco÷rdinatie Data Centrum van de afdeling Hematologie
- Public TitleRNA-DC vaccination in multiple myeloma.
- Scientific TitleVaccination of Multiple Myeloma patients with RNA electroporated mature dendritic cells expressing multiple tumor antigens.
- hypothesisThe primary goal is to show the capability of monocyte-derived DC after RNA electroporation for multiple antigens to induce an immune response. The secondary objective is to show clinical response.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma (Kahler's disease), Vaccination, Immune therapy, Minimal residual disease
- Inclusion criteria1. Age 18-70 years;
2. Patients with stage II and III MM;
3. Complete remission (CR) or partial response (PR) following intensive therapy, including high dose melphalan and autologous stem cell transplantation;
4. Measurable minimal residual disease by M-component (complete of light chain) or molecular disease by BM Ig heavy chain rearrangement (ASO-PCR);
5. Myeloma cells expressing 2-3 of the 3 TAA used for vaccination, each in >20% of CD138+CD38++ plasma cells;
6. Interval of >6 months after completion of intensive chemotherapy;
7. Life expectancy >6 months;
8. Expected adequacy for follow-up including bone marrow evaluation;
9. Written Informed consent.
- Exclusion criteria1. Progressive disease (increase in M-component of >25% in the last 3 months);
2. Patients on immunosuppressive drugs;
3. Patients with active infections (viral, bacterial or fungal) that requires specific therapy;
4. Acute therapy must have been completed within 14 days prior to study treatment;
5. Patients with known allergy to shell fish (contains KLH);
6. Patients with pregnancy or lactation;
7. WHO performance status 4;
8. Allogeneic stem cell transplantation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2007
- planned closingdate1-nov-2009
- Target number of participants12
- InterventionsPatients monocytes will collected by apheresis. Patients will be vaccinated intravenous and intradermal at 4 occasions with 2 weeks interval. Monitoring will be done for toxicity, immune response and minimal residual disease.
- Primary outcomeIn 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 outcomeSecondary end-points are clinical responses and decrease of minimal residual disease by molecular monitoring (ASO-PCR).
- TimepointsPatients will be treated by 4 DC vaccinations at 2 weeks interval. In case of response the procedure can be repeated to boost the immune response.
For follow-up we will collect blood (at day 14, 28, 42, 56 and 70 after DC vaccination) and bone marrow aspirates (at 3, 6, 12 months after chemotherapy during 1st year).
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Universitair Medisch Centrum Sint Radboud Nijmegen, afd. Hematologie
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF), Stichting Nijmeegs Offensief Tegen Kanker
- PublicationsN/A
- Brief summaryPatients with multiple myeloma (MM) are treated with intensive chemotherapy, which frequently induces a status of minimal residual disease, but finally all patients will relapse. Allogeneic transplantation as a form of immunotherapy may prolong remission and even cures the disease, but only in a minority of the patients and with significant toxicity. In a pilot study we vaccinated MM patients with mature DC loaded with idiotype as an alternative form of immunotherapy. We showed the feasibility and a very limited toxicity, but the idiotype antigen appeared only weakly immunogenic. In this study we will vaccinate with 3 different proteins, Mage-3, Survivin and BCMA, all shown to be highly expressed on malignant plasma cells. Autologous mature DC, electroporated with tumor associated antigen messenger RNA, will be used to present the antigens to the immune system.
- Main changes (audit trail)
- RECORD15-okt-2007 - 20-mrt-2008

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