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

NCT00001561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-09-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Myeloma Immunoglobulin Idiotype Vaccine-KLH

DRUG

GM-CSF

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-11-30
Completion
2005-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001561 on ClinicalTrials.gov