This trial is active, not recruiting.

Conditions transplantation, homologous, transplantation, autologous, multiple myeloma, blood and marrow transplant (bmt)
Treatments autologous/allogeneic hct, cyclophosphamide, filgrastim, melphalan, peripheral blood stem cell transplantation, total nodal irradiation, anti-thymocyte globulin, cyclosporine, mycophenolate mofetil, nonmyeloablative allogeneic hematopoietic stem cell transplantation, laboratory biomarker analysis
Phase phase 2
Sponsor Stanford University
Start date May 2009
End date November 2015
Trial size 43 participants
Trial identifier NCT00899847, BMT201, SU-04142009-2259


To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
autologous/allogeneic hct
Undergo autologous hematopoietic SCT
cyclophosphamide Ciclofosfamida
Given IV
filgrastim G-CSF
Given SC
melphalan L-PAM
Given IV
peripheral blood stem cell transplantation PBPC transplantation
Undergo allogeneic SCT
total nodal irradiation TLI
Undergo TLI
anti-thymocyte globulin ATG
Given IV
cyclosporine ciclosporin
Given PO
mycophenolate mofetil MMF
Given PO
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo allogeneic SCT
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Incidence of Graft-versus-host disease
time frame: wo years after the last participant is enrolled.

Secondary Outcomes

Relapse, Event free survival, Overall survival
time frame: Two years after the study closes to accrual

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 3.1.1 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. 3.1.2 Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. 3.1.3 Age > 18 years and <= 75 years. 3.1.4 Karnofsky Performance Status > 70%. 3.1.5 Corrected DLCO > 60% 3.1.6 Left ventricle ejection fraction (LVEF) > 50%. 3.1.7 ALT and AST must be <= 2X normal. Total bilirubin <= 2 mg/dL unless hemolysis or Gilbert's disease. 3.1.8 Estimated creatinine clearance > 50 ml/min. 3.1.9 Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1. 3.1.10 Signed informed consent. 3.3 Donor Evaluation Inclusion Criteria 3.3.1 Age >=17. 3.3.2 HIV seronegative 3.3.3 Donor must be capable of giving signed, informed consent 3.3.4 No contraindication to the administration of G-CSF 3.3.5 Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate. Exclusion Criteria: 3.2.1 Prior allogeneic hematopoietic cell transplantation. 3.2.2 Uncontrolled active infection. 3.2.4 Uncontrolled congestive heart failure or angina. 3.2.5 Pregnancy or nursing patients will be excluded from the study. 3.2.6 Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation. 3.4 Donor Evaluation Exclusion Criteria 3.4.1 Serious medical or psychological illness. 3.4.2 Pregnant or lactating women are not eligible 3.4.3 Prior malignancies within the last 5 years except for non-melanoma skin cancers

Additional Information

Official title A Phase II Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients
Principal investigator Wen-Kai Weng
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Stanford University.