FM 140 vs FM100 Study in Patients With Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00505895

Run by

M.D. Anderson Cancer Center

People needed

52

Starts

2002-01-01

Expected to finish

2013-05-01

Last updated by the study team

2014-10-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory considered poor candidate for autologous transplant, b) Remission Consolidation in patients with Chromosome 13 abnormalities or plasma cell leukemia, c) All relapsing patients.
• Age up to 70 years.
• Related or unrelated donor who is HLA-compatible in at least 9/10 alleles (A,B, C, DRB1 and DQ) by molecular techniques.
• Zubrod Performance Score (PS)<2.
• Life expectancy is not severely limited by concomitant illness. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) >40%.
• Patient and donor or guardian willing and able to sign informed consent.

You may not qualify if…

• Patients with active central nervous system (CNS) disease are ineligible for this study as documented by clinical symptoms and/or testing.

Where it is running

• UT MD . Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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