Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma

University Hospital Carl Gustav Carus

Status and phase: Completed; Phase 1

Conditions: Plasmocytoma; Multiple Myeloma

Treatments: Biological: autologous idiotype-protein pulsed dendritic cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00988312

MyelomVak

Details and patient eligibility

About

Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• multiple myeloma
• stage I (Salmon & Durie)
• no cytoreductive pre-treatment

Exclusion criteria

• myeloma stages II-III
• asecretory disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

s.c. vaccination

Experimental group

Description:

vaccine given subcutaneously

Treatment:

Biological: autologous idiotype-protein pulsed dendritic cells

i.v. vaccination

Experimental group

Description:

vaccines are given intravenously

Treatment:

Biological: autologous idiotype-protein pulsed dendritic cells