Clinical trial · Interventional
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
NCT00185614CI-TRIAL-00031254completedPhase 2Results postedClinicalTrials.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)
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Cancer | Liquid Tumor | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic cell transplant (Allo-HCT) | Procedure | — | UNRESOLVED |
| Autologous hematopoietic cell transplant (Auto-HCT) | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporine (CSP) | Procedure | — | UNRESOLVED |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Mycophenolate Mofetil (MMF) | Drug | — | UNRESOLVED |
| Total body irradiation (TBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Auto- then Allo-HCT
- description
- Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
- interventionNames
- Procedure: Autologous hematopoietic cell transplant (Auto-HCT)
- Procedure: Allogeneic hematopoietic cell transplant (Allo-HCT)
- Drug: Cyclophosphamide
- Drug: Filgrastim
- Drug: Melphalan
- Radiation: Total body irradiation (TBI)
- Procedure: Cyclosporine (CSP)
- Drug: Mycophenolate Mofetil (MMF)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
PATIENT INCLUSION CRITERIA * Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease * Patient has HLA-identical sibling donor * Age ≤ 70 years * No prior therapy which would preclude the use of low-dose total body irradiation * Pathology review and diagnosis confirmation by Stanford University Medical Center * Karnofsky performance status (KPS) \> 70% * DLCO ≥ 60% predicted * ALT and AST \< 2 x upper limit of normal (ULN) * Total bilirubin \< 2 mg/dL * Serum creatinine \< 2.0, or 24-hour creatinine clearance ≥ 60 mL/min * HIV-negative * Signed informed consent document PATIENT EXCLUSION CRITERIA * Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis * Severe psychological or medical illness * Prior allogeneic hematopoietic cell transplantation * Pregnant or lactating ALLOGENEIC DONOR INCLUSION CRITERIA * Age ≥ 17 * HIV-seronegative * Signed informed consent document ALLOGENEIC DONOR EXCLUSION CRITERIA * Serious medical or psychological illness * Pregnant or lactating * Prior malignancies within the last 5 years, except for non-melanoma skin cancers
References
Publications (0)
Data not yet available
No reference posted for this study.