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Mixed Chimera Allogeneic Transplantation With or Without Allogeneic Idiotyped Pulsed Dendritic Cells for the Treatment of Multiple Myeloma


Phase 2
18 Years
70 Years
Not Enrolling
Both
Blood Cancer, Multiple Myeloma

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Trial Information

Mixed Chimera Allogeneic Transplantation With or Without Allogeneic Idiotyped Pulsed Dendritic Cells for the Treatment of Multiple Myeloma


Inclusion Criteria:



- Multiple myeloma. 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.

- Age less than or equal to 70 years.

- No prior therapy which would preclude the use of low-dose total body irradiation.

- 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 primary amyloidosis will be excluded from this
study.

- Patients must have a Karnofsky performance status greater than 70%.

- DLCO >=60% predicted.

- ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl.

- Serum creatinine < 2.0 or 24-hour creatinine clearance >=60 ml/min.

- Patients must be HIV negative.

- Pregnant or lactating women will not be eligible to participate.

- Patients must provide signed, informed consent.

- Patients must have an HLA-identical sibling donor.

Exclusion Criteria:

- Severe psychological or medical illness

- Patients who have undergone prior allogeneic hematopoietic cell transplantation will
not be eligible for this study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Survival, event-free survival and relapse rate with an intent-to-treat analysis. Results will be compared to allogeneic HCT reported results.

Outcome Time Frame:

July 2011

Safety Issue:

No

Principal Investigator

Wen-Kai Weng

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT109

NCT ID:

NCT00185614

Start Date:

August 2000

Completion Date:

April 2010

Related Keywords:

  • Blood Cancer
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317