RNA-DC vaccination in multiple myeloma.

Vaccination of Multiple Myeloma patients with RNA electroporated mature dendritic cells expressing multiple tumor antigens.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27113

Enrollment

Registered

2007-10-15

Start date

2007-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. DC vaccination

Interventions

Patients 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

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

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 and decrease of minimal residual disease by molecular monitoring (ASO-PCR).	—

Contacts

Public ContactO. Huber

Universitair Medisch Centrum Sint Radboud Datacentrum Hematologie Intern adres 476 Geert Grooteplein zuid 10

Datacentrum@HEMAT.umcn.nl024 3614794

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)