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

• Status: Completed
• Trial end date: 2005-09-01

Summary

Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B. The following acronyms are used:

ABM Allogeneic Bone Marrow

BU Busulfan, NSC-750

CF Leucovorin calcium, NSC-3590

CTX Cyclophosphamide, NSC-26271

G-CSF Granulocyte Colony-Stimulating Factor (source not specified)

GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor (Hoechst/Immunex), NSC-613795

GVHD Graft-vs.-Host Disease

Mesna Mercaptoethane sulfonate, NSC-113891

MTX Methotrexate, NSC-740

PP Unconjugated Myeloma Immunoglobulin plasma paraprotein, NSC-684150

PP-KLH Myeloma immunoglobulin plasma paraprotein vaccine, NSC-678327, with keyhole limpet hemocyanin

TBI Total-Body Irradiation

TSPA Thiotepa, NSC-6396

Regimen A (Donor and Patient): Vaccine Therapy with Immunoadjuvant. PP-KLH (individual myeloma immunoglobulin plasma paraprotein vaccine prepared from recipient's plasma paraprotein and conjugated with KLH); and PP; with GM-CSF.

Regimen B (Patient): Myeloablative Radiotherapy and 2-Drug Combination Chemotherapy or 2-Drug Combination Myeloablative Chemotherapy followed by Hematopoietic Rescue with Growth Factor Support and GVHD Prophylaxis followed by Vaccine Therapy with Immunoadjuvant. TBI; and CTX/TSPA; or BU/CTX; followed by ABM; with G-CSF; and CYSP; MTX/CF; followed by PP-KLH; with GM-CSF.

• Phase: Phase 3

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Immunoglobulin Idiotypes; Immunoglobulins; Immunoglobulins, Intravenous; Myeloma Proteins; Paraproteins; Vaccines