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

Herlev Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed Multiple Myeloma

Interventions

peptides derived from antiapoptotic proteinsBIOLOGICAL

8 Vaccinations on day 2 and 9 in every bortezomib treatment series

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Haematology, Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Number of participants with adverse events

Time frame: 15 months

Data from ClinicalTrials.gov

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