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

Phase 3
18 Years
60 Years
Not Enrolling
Graft vs Host Disease, Multiple Myeloma

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Trial Information

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

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 that tumor antigen-specific
immunity can be adoptively transferred to BMT recipients by active immunization of marrow
transplant donors with purified myeloma idiotype protein, conjugated to a carrier protein
(KLH) and administered with GM-CSF as an immunological adjuvant.

Patients under age 60 with an HLA-matched sibling donor, with minimal prior treatment,
defined by less than six months prior chemotherapy, and who are in a minimal residual
disease state prior to allogeneic BMT, as defined by the achievement of at least a PR, are
eligible. HLA matched sibling donors receive a series of three vaccinations during an eight
week period prior to bone marrow harvest. Recipients concurrently receive vaccinations
pre-BMT, as well as three booster vaccinations at weeks 12, 16, and 24 post-BMT. Id-KLH
(0.5 mg) is administered s.c. GM-CSF (250 micrograms/m(2)) is administered s.c. locally with
the vaccine on the day of vaccination and for the three consecutive days following
vaccination. The objective of this protocol is to induce cellular and humoral immunity in
marrow transplant donors and recipients against the unique idiotype expressed by the
recipient's myeloma.

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.

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

November 1996

Completion Date:

September 2005

Related Keywords:

  • Graft Vs Host Disease
  • Multiple Myeloma
  • Multiple Myeloma
  • Vaccine
  • Idiotype-Specific Immunity
  • Immune Transfer
  • Myeloma Immunoglobulin
  • Graft vs Host Disease
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



National Cancer Institute (NCI) Bethesda, Maryland  20892