Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma
Phase 1
Completed
- Conditions
- Relapsed Multiple Myeloma
- Interventions
- Biological: peptides derived from antiapoptotic proteins
- Registration Number
- NCT01272466
- Lead Sponsor
- Herlev Hospital
- Brief Summary
Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. Patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory adjuvant. The vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- clinical diagnosis of multiple myeloma
- tissue type of HLA-A1, HLA-A2 or HLA-A3
- Performance status < 2
- Adequate bone marrow - renal and liver function
- written informed concent
Exclusion Criteria
- candidate for bone marrow transplantation
- other malignancies than multiple myeloma
- other significant medical disease (heart-, lung or liver disease or diabetes)
- allergy
- active autoimmune disease
- treatment with immunosuppressive drugs
- treatment with other experimental drugs
- uncontrolled hypercalcemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description peptides from antiapoptotic proteins peptides derived from antiapoptotic proteins -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events 15 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Haematology, Odense University Hospital
🇩🇰Odense, Denmark