Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University; Wen-Kai Weng
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Lenograstim; Melphalan; Mycophenolate mofetil; Mycophenolic Acid; Sargramostim

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