Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Stem Cell Infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fludarabine + Melphalan + Stem Cell Infusion
- description
- 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.
- interventionNames
- Drug: Melphalan
- Drug: Fludarabine
- Procedure: Stem Cell Infusion
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
- description
- 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.
- interventionNames
- Drug: Melphalan
- Drug: Fludarabine
- Procedure: Stem Cell Infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available