Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma

Relapsed Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272466
• Other study ID #: 2006-003619-29
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2010
• Est. completion date: January 1, 2015

Study information

• Verified date: August 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2015
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed Multiple Myeloma

Intervention

Biological:
• peptides derived from antiapoptotic proteins
8 Vaccinations on day 2 and 9 in every bortezomib treatment series

Locations

Country	Name	City	State
Denmark	Department of Haematology, Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		15 months