Multiple Myeloma Clinical Trial
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
Summary
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Full Description
Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.
Eligibility Criteria
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
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There is 1 Location for this study
Stanford California, 94305, United States
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