Phase 2
Completed N=50
FM 140 vs FM100 Study in Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT00505895 ↗Enrolled (actual)
50
Serious AEs
78.0%
Results posted
Oct 2014
Primary outcomePrimary: Number of Participants With Successful Engraftment at Day 100 — 27; 23 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Engraftment at Day 100 |
27; 23 | — |
| SECONDARY Acute Grade II-IV Graft Versus Host Disease (GVHD) |
22; 21; 29; 48 | — |
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) 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
- Patients with active central nervous system (CNS) disease are ineligible for this study as documented by clinical symptoms and/or testing.
Data sourced from ClinicalTrials.gov (NCT00505895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.