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A Phase II Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Transplantation, Homologous, Transplantation, Autologous, Multiple Myeloma, Blood and Marrow Transplant (BMT)

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Trial Information

A Phase II Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Graft-versus-host disease

Outcome Time Frame:

wo years after the last participant is enrolled.

Safety Issue:

Yes

Principal Investigator

Wen-Kai Weng

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT201

NCT ID:

NCT00899847

Start Date:

May 2009

Completion Date:

November 2016

Related Keywords:

  • Transplantation, Homologous
  • Transplantation, Autologous
  • Multiple Myeloma
  • Blood and Marrow Transplant (BMT)
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Stanford University School of MedicineStanford, California  94305-5317