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FM 140 vs FM100 Study in Patients With Multiple Myeloma

NCT00505895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-10-17

Study results available
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Summary

The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.

Conditions

Interventions

DRUG

Melphalan

Arm 1 = 140 mg/m\^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m\^2 intravenous over 20 Minutes on Day -1.

DRUG

Fludarabine

30 mg/m\^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).

PROCEDURE

Stem Cell Infusion

Stem Cell Infusion on Day 0.

DRUG

Rituximab

375 mg/m\^2 intravenous on Day -5, +2 +9 and +16.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Muzaffar H. Qazilbash, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

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 NCT00505895 on ClinicalTrials.gov