Search / Trial NCT00001561

Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Multiple Myeloma Vaccine Idiotype Specific Immunity Immune Transfer Myeloma Immunoglobulin

Description

Multiple Myeloma remains a largely incurable disease with current therapy. Allogeneic bone marrow transplantation provides an opportunity to add the potential antitumor effect of marrow grafts to those of high dose chemotherapy. One potential strategy for enhancing a graft vs. tumor effect without aggravating graft vs. host disease would be to selectively target an immune response against a defined tumor-specific antigen. The idiotype of the rearranged immunoglobulin gene product of a myeloma can serve as a unique tumor-specific antigen for vaccine development. We are testing the hypothesis...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Patient Selection:
  • Patients with IgG or IgA multiple myeloma who attain at least a PR before transplantation are eligible for thsi protocol.
  • Patients may only have received 3-4 courses of VAD, high dose cyclophosphamide and one autologous transplant before entering the study.
  • All previous therapy must be completed at least 2 weeks prior to study entry.
  • Patients should have recovered from all hematologic and non-hematologic toxicity of previous therapy.
  • Steroid must be discontinued at least two weeks prior to vaccination.
  • Only patients less than 60 years are eligible for this protocol.
  • Patients must meet the following criteria:
  • A. Karnofsky performance status greater than or equal to 70 percent.
  • B. Life expectancy greater than 8 weeks and absence of co-existing medical problems which would significantly increase the risk of the transplant procedure in the judgment of the bone marrow transplant attending physicians (e.g., the MUGA left ventricular ejection fraction has to be greater than 50% and DLCO greater thant 50% of the expected value when corrected for Hb).
  • Creatinine less than 2x normal and not rising for at least 2-4 weeks before transplantation. If creatinine is elevated, then creatinine clearance must be greater than 40 ml/min.
  • Direct bilirubin less than 2 mg/dl, SGOT less than 4x top normal, and none of these parameters increasing, for at least 2-4 weeks before transplantation.
  • Patients must be HIV-negative, HBsAg-, and Hepatitis C antibody Negative.
  • Not pregnant or lactating. Patients of childbearing potential must use an effective method of contraception.
  • M-protein concentration in the harvested plasma must be greater than 90 percent of the total Ig of the corresponding isotype.
  • Patients must be greater than or equal to 18 years old.
  • Donor criteria:
  • Any consenting healthy individual who fulfills the donor criteria will be considered for the marrow donation.
  • HLA-identical sibling donors.
  • HLA, A and B and DR phenotypically identical family donors.
  • HIV, hepatitis B or C seropositive.
  • Complete blood count, platelets, and PT, PTT within normal limits.

Attachments

readout_NCT00001561_2024-03-02.pdf

4.5 MB

NCT00001561_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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