Multiple Myeloma
Conditions
Brief summary
The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.
Detailed description
The primary objective of the protocol is to evaluate the toxicity and tolerability of this mixed chimerism matched unrelated donor allogeneic transplant approach for patients with multiple myeloma. Response, toxicity, survival and graft-versus-host disease will be evaluated.
Interventions
PROCEDUREAutologous followed by non-myeloablative allogeneic transplantation
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
a) Multiple myeloma which is responsive to therapy. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease. Patients who have relapsed following autologous transplantation may be eligible for this protocol. b) Age \<= 60 years. c) No prior therapy which would preclude the use of low-dose total body irradiation. d) Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or amyloidosis will be excluded from this study. e) Patients must have a Karnofsky performance status \> 70%. f) DLCO \>= 60% predicted. g) ALT and AST must be \< 2X normal. Total bilirubin less than 2 mg/dl. h) Serum creatinine \< 2.0 or 24-hour creatinine clearance \>= 50 ml/min. i) Patients must be HIV negative. j) Pregnant or lactating women will not be eligible to participate. k) Patients must provide signed, informed consent.
Exclusion criteria
a) Severe psychological or medical illness b) Patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study. c) Patients who have an HLA-identical sibling donor will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants. | — |
Countries
United States
Outcome results
None listed