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Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

NCT00615589 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-04-04

Study results available
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Summary

Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.

This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.

Conditions

Interventions

DRUG

Fludarabine/Busulfan x 4 days

* Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. * Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.

PROCEDURE

stem cell transplant

Allogeneic, peripheral blood stem cell transplant

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Attaphol Pawarode, MD · University of Michigan Dept. of Internal Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00615589 on ClinicalTrials.gov