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Bone Marrow Transplant

Autologous or Syngeneic SCT Followed by Donor SCT for Multiple Myeloma (FHCRC-2070)
Tandem Autologous HCT / Nonmyeloablative Allogeneic HCT from HLA-Matched Related and Unrelated Donors Followed by Bortezomib Maintenance Therapy for Patients with High-Risk Multiple Myeloma
Status Conditions Phase Study ID
Recruiting Graft Versus Host Disease
Multiple Myeloma
Plasma Cell Neoplasm and Plasma Cell Neoplasm
Phase II FHCRC-2070
NCT00793572
Summary

RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving more chemotherapy together with total-body irradiation before a donor stem cell transplant helps stop the growth of any cancer cells that remain. It also stops the patient's immune system from rejecting the donor's stem cells. Undergoing an autologous or syngeneic stem cell transplant followed by a donor stem cell transplant and bortezomib may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of two different ways of giving an autologous or syngeneic stem cell transplant followed by a donor stem cell transplant and bortezomib and to see how well they work in treating patients with newly diagnosed high-risk, relapsed, or refractory multiple myeloma.


Investigator
Marco Mielcarek, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets Salmon/Durie criteria for initial diagnosis of multiple myeloma (MM)

    • Newly diagnosed disease
    • Relapsed or refractory disease
    • High-risk disease
  • Must meet ≥ 1 of the following criteria A-I (A-G at time of diagnosis or pre-autograft):

    • A: Any abnormal karyotype by metaphase analysis except for isolated t(11,14) and constitutional cytogenetic abnormality
    • B: FISH translocation 4;14
    • C: FISH translocation 14;16
    • D: FISH deletion 17p
    • E: β2-microglobulin > 5.5 mg/mL
    • F: Cytogenetic hypodiploidy
    • G: Plasmablastic morphology (≥ 2%)
    • H: Recurrent or non-responsive (< partial response) MM after ≥ 2 different lines of conventional chemotherapy
    • I: Progressive MM after a prior autograft (provided stored autologous CD34 cells are available)
  • Must have received induction therapy (e.g., vincristine, doxorubicin hydrochloride, and prednisone or thalidomide/dexamethasone) for ≥ 4 courses

    • No conventional induction therapy
    • May have failed prior autografts or ≥ 2 lines of prior chemotherapy
  • Available donor meeting any of the following criteria:

    • HLA genotypically identical sibling or phenotypically matched relative or, at a minimum, a high likelihood of identifying an HLA-matched unrelated donor
    • HLA phenotypically matched unrelated donor

      • Matched for serologically recognized HLA-A and B and C antigens, and ≥ 5/6 HLA-A and B and C alleles
      • Matched for HLA-DRB1 and DQB1 at the allele level (defined by high-resolution typing)
    • Not an identical twin
    • Positive anti-donor cytotoxic mismatch
Last Updated
July 12, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.