FM 140 vs FM100 Study in Patients With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Fludarabine, Fludara, Fludarabine Phosphate, Melphalan, Alkeran, Stem Cell Infusion, Stem Cell Transfusion, SCT, Allogeneic Peripheral Blood Stem Cell Transfusion, APBSCT, Bone Marrow Transplantation, BMT, Rituxan, Rituximab, FM140, FM100
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
1) Patients with active central nervous system (CNS) disease are ineligible for this study as documented by clinical symptoms and/or testing.
Sites / Locations
- UT MD . Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Fludarabine + Melphalan + Stem Cell Infusion
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5.
Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5.