We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mixed Chimera Allo Transplantation in Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185614
First Posted: September 16, 2005
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  Purpose
To determine toxicity and feasibility of mixed chimera allogeneic hematopoietic cell transplants for multiple myeloma; prepare and vaccinate patients with allogenic dendritic cell vaccinations following mixed chimera allogeneic hematopoietic cell transplants

Condition Intervention Phase
Blood Cancer Multiple Myeloma Procedure: autologous then nonmyeloablative allogeneic transplant Drug: cyclophosphamide Drug: Melphalan Drug: cyclosporin Drug: Mycophenolate mofetil Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mixed Chimera Allogeneic Transplantation With or Without Allogeneic Idiotyped Pulsed Dendritic Cells for the Treatment of Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Survival, event-free survival and relapse rate with an intent-to-treat analysis. Results will be compared to allogeneic HCT reported results. [ Time Frame: July 2011 ]

Secondary Outcome Measures:
  • Development of Graft Versus Host Disease (GVHD) in vaccinated patients [ Time Frame: July 2011 ]
  • Development of GVHD in concurrent myeloma patients receiving allogeneic HCT at our institution who are not candidates for vaccination. [ Time Frame: July 2011 ]

Enrollment: 48
Study Start Date: August 2000
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: autologous then nonmyeloablative allogeneic transplant
    stem cell transplantation
    Other Names:
    • BMT
    • Blood and Marrow Transplantation
    Drug: cyclophosphamide
    4 gm/m2, IV
    Other Names:
    • Endoxan
    • Cytoxan
    • Neosar
    • Procytox
    • Revimmune
    • cytophosphane
    Drug: Melphalan
    200 mg/m2; iv
    Other Names:
    • Alkeran
    • Melphalan hydrochloride
    Drug: cyclosporin
    5 mg/kg; iv or po
    Other Names:
    • cyclosporine
    • cyclosporin A
    Drug: Mycophenolate mofetil
    15 mg/kg
    Other Names:
    • MMF
    • CellCept
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185614


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Wen-Kai Weng Stanford University
  More Information

Responsible Party: Wen-Kai Weng, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185614     History of Changes
Other Study ID Numbers: BMT109
75190 ( Other Identifier: Stanford University Alternate IRB Approval No. )
BMT109 ( Other Identifier: Stanford University )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: April 19, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Cyclophosphamide
Cyclosporins
Cyclosporine
Melphalan
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists