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Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

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. Identifier: NCT00615589
Recruitment Status : Terminated (Low accrual)
First Posted : February 14, 2008
Results First Posted : December 11, 2014
Last Update Posted : April 4, 2016
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:

Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.

This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Plasma Cell Leukemia Drug: Fludarabine/Busulfan x 4 days Procedure: stem cell transplant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Study Start Date : February 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Flu-Bu4
Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Drug: Fludarabine/Busulfan x 4 days
  • Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.
  • Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.

The Fludarabine shall be administered prior to the Busulfan each day.

Procedure: stem cell transplant
Allogeneic, peripheral blood stem cell transplant

Primary Outcome Measures :
  1. The Percentage of Patients Alive 1 Year Post Transplant [ Time Frame: 1 Year ]
    The primary objective is overall survival, one year from the time of transplant.

Secondary Outcome Measures :
  1. The Percentage of Patients Free From Progression at 1 Year [ Time Frame: 1 Year ]

    One of the secondary outcomes that will be measured is progression free survival at 1 Year.

    Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.

  2. Percentage of Patients With Treatment Related Mortality (TRM) [ Time Frame: 100 days, one-year ]
  3. Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD) [ Time Frame: 100 days, 2 years ]

    Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.

    Acute GVHD Grading:

    Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus

  4. Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression [ Time Frame: 3 years ]
    Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Biologic high risk Multiple Myeloma:

    • Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics.

      • Relapsed or persistent multiple myeloma after ASCT.
      • Persistent multiple myeloma, regardless of previous therapies.
      • Plasma cell leukemia, regardless of previous therapies.
  • Age up to 70 years old (less than 71 years old at the date of transplant admission).
  • Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission
  • Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant.
  • Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission)

Exclusion Criteria:

  • Persistent invasive infections, not controlled by antimicrobials.
  • HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity.
  • Uncontrolled medical or psychiatric disorder.
  • No response or progressive disease at the time of transplantation.
  • Pregnancy

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 identifier (NCT number): NCT00615589

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United States, Michigan
University of Michigan,Department of Internal Med. Hematology- Oncology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Principal Investigator: Attaphol Pawarode, MD University of Michigan Dept. of Internal Medicine

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Responsible Party: University of Michigan Rogel Cancer Center Identifier: NCT00615589     History of Changes
Other Study ID Numbers: umcc 2007.074
First Posted: February 14, 2008    Key Record Dates
Results First Posted: December 11, 2014
Last Update Posted: April 4, 2016
Last Verified: March 2016
Keywords provided by University of Michigan Rogel Cancer Center:
Stage II/III Multiple Myeloma(within 10 months from diagnosis)
high risk
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists