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.

Lead Sponsor:

Stanford University

Intervention(s):

  • 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

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822