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Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 8, 2009
Last updated: August 6, 2013
Last verified: June 2011

RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.

Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Biological: autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine
Biological: autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine
Biological: autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Immune response [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2003
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • Evaluation of feasibility of dendritic cell (DC)-based vaccination program using autologous tumor cells and/or lysates in patients with indolent B cell lymphomas or multiple myeloma as an adjuvant therapy to induce immune response in remission after cytoreductive treatment.
  • Evaluation of the immune response of patients treated with this regimen.
  • Evaluation the progression-free survival of patients treated this regimen.
  • Evaluate the adverse events of this regimen in these patients.

OUTLINE: Patients receive intranodal (under ultrasound guidance) or subcutaneous vaccinations of adjuvant electrofusion hybrids of autologous dendritic cells (DC) with autologous lymphoma cells, electrofusion hybrids of allogeneic DC with autologous lymphoma cells, and/or autologous DC pulsed with autologous tumor lysate cells in weeks 0, 2, 4, 8, 12, 18, 26, and 50.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed diagnosis of 1 of the following:

    • Mantle cell lymphoma
    • Marginal zone lymphoma
    • Follicular lymphoma
    • Small lymphocytic lymphoma/chronic lymphocytic leukemia
    • Multiple myeloma
    • Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia
    • Diffuse large B-cell lymphoma
  • Adequate sample size and lymphoma cell content in the fresh tissue collected
  • No bulky or progressive disease


  • Life expectancy > 3 months
  • No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
  • No autoimmune disease or atopic allergy
  • No HIV positivity
  • No other malignancy


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00937183

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland, 02-781
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Study Chair: Jan Walewski, MD Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
  More Information Identifier: NCT00937183     History of Changes
Other Study ID Numbers: MSCMI-40-2003  CDR0000636859  EU-20913 
Study First Received: July 8, 2009
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
Waldenström macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage II grade 1 follicular lymphoma
stage II grade 2 follicular lymphoma
stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage I small lymphocytic lymphoma
stage II small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage I marginal zone lymphoma
stage II marginal zone lymphoma
stage III marginal zone lymphoma
stage I adult diffuse large cell lymphoma
stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
B-cell chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunologic Factors
Physiological Effects of Drugs processed this record on December 02, 2016