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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


Phase 1/Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Relapsed Multiple Myeloma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Outcome Time Frame:

15 months

Safety Issue:

Yes

Principal Investigator

Lene M Knudsen, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Haematology, Odense University Hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

2006-003619-29

NCT ID:

NCT01272466

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Relapsed Multiple Myeloma
  • multiple myeloma
  • vaccination
  • antiapoptotic proteins
  • proteasome inhibition
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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