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OpenTrials
Completed

NCT Number: NCT00988312

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Plasmacytoma Plasmocytoma Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Dresden

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • myeloma stages II-III
  • asecretory disease

Treatment and study plan

autologous idiotype-protein pulsed dendritic cells

Biological

Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks

Primary outcomes

  1. Specific T-cell proliferation/cytokine secretion

Secondary outcomes

  1. number of T cells

    Time frame: pre and post vaccination

  2. monoclonal protein

    Time frame: pre and post vaccination

  3. plasmacells in bone marrow

    Time frame: pre and post vaccination

  4. vital signs

    Time frame: pre and post vaccination

Sponsors and collaborators

Lead sponsor

University Hospital Carl Gustav Carus

Other

Registry information

Official study title

Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Oct 2, 2009
Registry last updated
Oct 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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