Trial Search Results
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Stanford is currently not accepting patients for this trial.
- 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
- Drug: Acetaminophen
- Drug: Hydrocortisone
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
- 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
PARTICIPANT EXCLUSION CRITERIA
- Prior allogeneic hematopoietic cell transplantation
- Uncontrolled active infection
- Uncontrolled congestive heart failure or angina
- 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
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study