Mixed Chimera Allo Transplantation in Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185614
First received: September 12, 2005
Last updated: April 18, 2011
Last verified: April 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of Graft Versus Host Disease (GVHD) in vaccinated patients [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
  • Development of GVHD in concurrent myeloma patients receiving allogeneic HCT at our institution who are not candidates for vaccination. [ Time Frame: July 2011 ] [ Designated as safety issue: No ]

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
    • cyclosporin A
    Drug: Mycophenolate mofetil
    15 mg/kg
    Other Names:
    • MMF
    • CellCept
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, BMT109
Study First Received: September 12, 2005
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematologic Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Paraproteinemias
Vascular Diseases
Cyclophosphamide
Cyclosporine
Cyclosporins
Melphalan
Mycophenolate mofetil
Mycophenolic Acid
Alkylating Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 23, 2014