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High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant

NCT00637767 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-12-23

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. A stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by the chemotherapy and radiolabeled monoclonal antibody.

PURPOSE: This randomized phase II trial is studying how well high-dose melphalan works when given with or without radiolabeled monoclonal antibody in treating patients with multiple myeloma undergoing an autologous stem cell transplant.

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Interventions

DRUG

melphalan

PROCEDURE

autologous hematopoietic stem cell transplantation

RADIATION

yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183

Sponsors & Collaborators

  • NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust

    collaborator UNKNOWN

  • European Federation of Pharmaceutical Industries and Associations

    collaborator UNKNOWN

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • The Periscope Consortium

    collaborator UNKNOWN

  • Q-Biologicals NV

    collaborator UNKNOWN

  • University of Southampton

    lead OTHER

Principal Investigators

  • Kim Orchard, MD · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-01
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT00637767 on ClinicalTrials.gov