Multiple Myeloma Clinical Trial
Official title:
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
Verified date | October 2014 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. Age up to 70 years. 3. Related or unrelated donor who is HLA-compatible in at least 9/10 alleles (A,B, C, DRB1 and DQ) by molecular techniques. 4. Zubrod Performance Score (PS)<2. 5. 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%. 6. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UT MD . Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Successful Engraftment at Day 100 | Day 100 | No | |
Secondary | Acute Grade II-IV Graft Versus Host Disease (GVHD) | Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade =2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4. | GVHD grading weekly during first 100 days; Annual examinations for nine year study period | Yes |
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