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

Herlev Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Relapsed Multiple Myeloma

Treatments: Biological: peptides derived from antiapoptotic proteins

Study type: Interventional

Funder types: Other

Identifiers

NCT01272466

2006-003619-29

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

peptides from antiapoptotic proteins

Experimental group

Treatment:

Biological: peptides derived from antiapoptotic proteins