FM 140 vs FM100 Study in Patients With Multiple Myeloma
A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
1 other identifier
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Jan 2002
Longer than P75 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 20, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
October 17, 2014
CompletedOctober 17, 2014
October 1, 2014
11.3 years
July 20, 2007
October 3, 2014
October 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Successful Engraftment at Day 100
Day 100
Secondary Outcomes (1)
Acute Grade II-IV Graft Versus Host Disease (GVHD)
GVHD grading weekly during first 100 days; Annual examinations for nine year study period
Study Arms (2)
Fludarabine + Melphalan + Stem Cell Infusion
EXPERIMENTALFludarabine 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 + Lower-Dose Melphalan + Stem Cell Infusion
EXPERIMENTALFludarabine 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.
Interventions
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.
30 mg/m\^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).
Stem Cell Infusion on Day 0.
375 mg/m\^2 intravenous on Day -5, +2 +9 and +16.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD . Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Muzaffar Qazilbash, MD / Professor, Stem Cell Transplantation
- Organization
- University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Muzaffar H. Qazilbash, MD
UT MD Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2007
First Posted
July 25, 2007
Study Start
January 1, 2002
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
October 17, 2014
Results First Posted
October 17, 2014
Record last verified: 2014-10