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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01272466

Enrollment

Registered

2011-01-07

Start date

2010-02-28

Completion date

2015-01-01

Last updated

2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed Multiple Myeloma

Keywords

multiple myeloma, vaccination, antiapoptotic proteins, proteasome inhibition

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.

Interventions

BIOLOGICALpeptides derived from antiapoptotic proteins

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	15 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026