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

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615589
First Posted: February 14, 2008
Last Update Posted: April 4, 2016
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.
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • 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:
  • 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.


  • Percentage of Patients With Treatment Related Mortality (TRM) [ Time Frame: 100 days, one-year ]
  • 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


  • 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.


Enrollment: 22
Study Start Date: February 2008
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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:

  • 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
  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): NCT00615589


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

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00615589     History of Changes
Other Study ID Numbers: umcc 2007.074
HUM00014029
First Submitted: January 22, 2008
First Posted: February 14, 2008
Results First Submitted: December 3, 2014
Results First Posted: December 11, 2014
Last Update Posted: April 4, 2016
Last Verified: March 2016

Keywords provided by University of Michigan Cancer Center:
Stage II/III Multiple Myeloma(within 10 months from diagnosis)
high risk
relapse
persistent

Additional relevant MeSH terms:
Leukemia, Plasma Cell
Multiple Myeloma
Neoplasms, Plasma Cell
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
Leukemia
Fludarabine
Fludarabine phosphate
Busulfan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists