Stanford, California 94305

  • Multiple Myeloma

Purpose:

Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.


Study summary:

Participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (auto-HCT)]. Post-infusion support includes filgrastim 5 µg/kg/day, starting 6 days following melphalan. Participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic HCT (allo-HCT). For allo-HCT, a sibling donor that is fully matched for human leukocyte antigen (HLA-matched) is identified. Participants receive a single dose of total body irradiation (TBI) 200 centigray (cGy) as well as immunosuppression with cyclosporine (CSP) 6.25 mg/kg and mycophenolate mofetil (MMF) 15 mg/kg. The HLA-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to Day 0, with apheresis collections on Day -1 and Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV and diphenhydramine 50 mg IV. CSP will be tapered beginning Day 56 with a goal of discontinuing CSP on Day 180, adjusted as needed.


Criteria:

PATIENT INCLUSION CRITERIA - Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease - Patient has HLA-identical sibling donor - Age ≤ 70 years - No prior therapy which would preclude the use of low-dose total body irradiation - Pathology review and diagnosis confirmation by Stanford University Medical Center - Karnofsky performance status (KPS) > 70% - DLCO ≥ 60% predicted - ALT and AST < 2 x upper limit of normal (ULN) - Total bilirubin < 2 mg/dL - Serum creatinine < 2.0, or 24-hour creatinine clearance ≥ 60 mL/min - HIV-negative - Signed informed consent document PATIENT EXCLUSION CRITERIA - Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis - Severe psychological or medical illness - Prior allogeneic hematopoietic cell transplantation - Pregnant or lactating ALLOGENEIC DONOR INCLUSION CRITERIA - Age ≥ 17 - HIV-seronegative - Signed informed consent document ALLOGENEIC DONOR EXCLUSION CRITERIA - Serious medical or psychological illness - Pregnant or lactating - Prior malignancies within the last 5 years, except for non-melanoma skin cancers


NCT ID:

NCT00185614


Primary Contact:

Principal Investigator
Wen-Kai Weng, MD
Stanford University


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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