Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma
Conditions
Relapsed Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
multiple myeloma, vaccination, antiapoptotic proteins, proteasome inhibition
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: peptides derived from antiapoptotic proteins
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Department of Haematology, Odense University Hospital
Odense, Denmark
Status: Recruiting
Contact: Lene M Knudsen, M.D. - +4565411850 - lene.meldgaard.knudsen@ouh.regionsyddanmark.dk
Start Date
February 2010
Sponsors
Herlev Hospital
Source
Herlev Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page