Clinical trial · Interventional
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients
NCT00899847CI-TRIAL-00029999completedPhase 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)
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Conditions
Conditions (4)
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 and Marrow Transplant (BMT) | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Transplantation, Autologous | — | UNRESOLVED | — |
| Transplantation, Homologous | — | UNRESOLVED | — |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Allogeneic peripheral blood stem cells (allo-PBSC) transplantation | Procedure | — | UNRESOLVED |
| Autologous peripheral blood stem cells (auto-PBSC) transplantation | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporine | Drug | — | UNRESOLVED |
| Diphenhydramine | Drug | — | UNRESOLVED |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Hydrocortisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
- description
- Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
- interventionNames
- Procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation
- Procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation
- Drug: Filgrastim
- Drug: Cyclophosphamide
- Drug: Melphalan
- Drug: Cyclosporine
- Radiation: Total lymphoid irradiation
- Biological: Rabbit anti-thymocyte globulin
- Drug: Mycophenolate Mofetil 250mg
- Drug: Solumedrol
- Drug: Diphenhydramine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
PARTICIPANT INCLUSION CRITERIA * Stage II-III multiple myeloma or have progression after initial treatment of Stage I disease (Durie Salmon Staging). Patients with plasma cell leukemia are also included. * Multiple myeloma / plasma cell leukemia diagnosis confirmed by pathology reviewed at Stanford University Medical Center. * 18 to ≤ 75 years of age * Karnofsky Performance Status \> 70%. * Corrected Carbon monoxide diffusing capacity (Dlco) \> 60% * Left ventricle ejection fraction (LVEF) \> 50%. * Alanine aminotransferase (ALT) ≤ 2 x normal * Aspartate aminotransferase (AST) ≤ 2 x normal * Total bilirubin ≤ 2 mg/dL, unless hemolysis or Gilbert's disease. * Estimated creatinine clearance \> 50 mL/min. * Identified related or unrelated Human leukocyte antigen (HLA)-identical donor or donor with one antigen/allele mismatch in (HLA-A, B, C or DRB1). * Signed informed consent. DONOR INCLUSION CRITERIA * At least 17 years of age * HIV-seronegative * Must be capable of giving signed, informed consent * No contraindication to the administration of filgrastim * Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate PARTICIPANT EXCLUSION CRITERIA * Prior allogeneic hematopoietic cell transplantation * Uncontrolled active infection * Uncontrolled congestive heart failure or angina * HIV-positive * Pregnant or nursing 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.