Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedAugust 31, 2018
August 1, 2018
2 years
January 3, 2011
August 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
15 months
Study Arms (1)
peptides from antiapoptotic proteins
EXPERIMENTALInterventions
8 Vaccinations on day 2 and 9 in every bortezomib treatment series
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
- Odense University Hospitalcollaborator
Study Sites (1)
Department of Haematology, Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene M Knudsen, M.D
Department of Haematology, Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 7, 2011
Study Start
February 1, 2010
Primary Completion
February 1, 2012
Study Completion
January 1, 2015
Last Updated
August 31, 2018
Record last verified: 2018-08