Status:
COMPLETED
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
Lead Sponsor:
Stanford University
Conditions:
Transplantation, Homologous
Transplantation, Autologous
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Detailed 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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00899847
Start Date
May 1 2009
End Date
December 1 2014
Last Update
October 20 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305