Clinical trial · Interventional
Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
NCT00968396CI-TRIAL-00009926withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis | Procedure | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Stem Cell Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stem Cell Collection + Transplantation
- description
- Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m\^2 IV over 30 minutes daily on Days -2 and -1.
- interventionNames
- Procedure: Apheresis
- Procedure: Stem Cell Transplantation
- Drug: Melphalan
Primary outcomes (1)
- measure
- Neutrophil Engraftment Rate
- timeFrame
- 28 Days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with multiple myeloma who have relapsed after an autologous transplant or with a chemosensitive relapse more than one year post initial therapy 2. Age 18 to 75 years 3. Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias 4. FEV1, FVC and DLCO \>/= 40%. No symptomatic pulmonary disease 5. Serum bilirubin \</= 2 x upper limit of normal, SGPT \</= 4 x upper limit of normal 6. HIV-negative 7. Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization 8. Patient or guardian able to sign informed consent 9. Marrow-MSC Donor Requirements: patients must have a family member who is matched at 2, 3, or 4 HLA antigens and willing to donate 80-100 ml or bone marrow for MSC generation Exclusion Criteria: 1. International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin \< 3.5 mg/L and albumin \>/= 3.5 g/dL) 2. Patients with an apheresis collection \</= 7 x 10e6 CD34+/Kg 3. A fully matched related donor
References
Publications (0)
Data not yet available
No reference posted for this study.