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Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT00054353 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-10-16

Study results available
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Summary

This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.

Conditions

  • Refractory Multiple Myeloma

Interventions

DRUG

fludarabine phosphate

Given IV

DRUG

melphalan

Given IV

RADIATION

total-body irradiation

Undergo TBI

DRUG

mycophenolate mofetil

Given PO

DRUG

cyclosporine

Given PO

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo reduced-intensity allogeneic PBSCT

PROCEDURE

peripheral blood stem cell transplantation

Undergo reduced-intensity allogeneic PBSCT

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Marco Mielcarek · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2009-10-31
Completion
2012-10-14

Countries

  • United States
  • Italy

Study Locations

More Related Trials

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 NCT00054353 on ClinicalTrials.gov