Trial Information
Vaccination With Peptides Derived From Anti-apoptotic Proteins From the Bcl-2 Family, Administered in Combination With Montanide ISA-51 in Relation to Treatment With Proteasome Inhibitors in Patients With Relapsed Multiple Myeloma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with adverse events
Outcome Time Frame:
15 months
Safety Issue:
Yes
Principal Investigator
Lene M Knudsen, M.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Haematology, Odense University Hospital
Authority:
Denmark: Danish Medicines Agency
Study ID:
2006-003619-29
NCT ID:
NCT01272466
Start Date:
February 2010
Completion Date:
Related Keywords:
- Relapsed Multiple Myeloma
- multiple myeloma
- vaccination
- antiapoptotic proteins
- proteasome inhibition
- Multiple Myeloma
- Neoplasms, Plasma Cell