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Chemotherapy, Vaccine Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024466
First received: September 13, 2001
Last updated: February 6, 2009
Last verified: October 2003
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with vaccine therapy and peripheral stem cell transplantation may be effective in treating multiple myeloma.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine therapy and peripheral stem cell transplantation in treating patients who have newly diagnosed multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
 Biological: autologous tumor cell vaccine
Drug: chemotherapy
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT

Resource links provided by NLM:

U.S. FDA Resources

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

Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of induction chemotherapy followed by autologous tumor cell vaccine and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
  • Determine the safety of this regimen in these patients.

OUTLINE: Autologous tumor cells are harvested. The vaccine is prepared in vitro by mixing autologous tumor cells with a bystander cell expressing sargramostim (GM-CSF). Patients receive induction chemotherapy followed by autologous tumor cell vaccination (ATCV) once. Patients then undergo autologous peripheral blood stem cell transplantation. At 6 weeks after transplantation, patients receive additional ATCVs every 3 weeks for a total of 8 vaccinations.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed multiple myeloma
  • More than 30% bone marrow involvement
  • Eligible for autologous peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 500/mm^3
  • Platelet count greater than 30,000/mm^3

Hepatic:

  • Bilirubin less than 3 times normal
  • AST/ALT less than 3 times normal

Renal:

  • Not specified

Other:

  • Not pregnant
  • HIV negative
  • No prior or active autoimmune disease
  • No other prior malignancy within the past 5 years
  • No major active medical or psychosocial problems

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • No more than 1 prior course of chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Concurrent local radiotherapy allowed

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024466

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Ivan Borrello, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00024466     History of Changes
Other Study ID Numbers: CDR0000068953, JHOC-J0115, JHOC-01011706, JHOC-K0007, NCI-G01-2020
Study First Received: September 13, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013