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

Completed

• Conditions: Kahler disease; Multiple myeloma; 10035227

• Registration Number: NL-OMON34526
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

· 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>