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

This study is ongoing, but not recruiting participants.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center Identifier:
First received: January 22, 2008
Last updated: August 19, 2013
Last verified: August 2013

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • overall survival, one year from the time of transplant [ Time Frame: one-year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: one-year ] [ Designated as safety issue: Yes ]
  • Treatment-related mortality [ Time Frame: 100 days, one-year ] [ Designated as safety issue: Yes ]
  • Incidence of acute and chronic GVHD [ Time Frame: 100 days, 2 years ] [ Designated as safety issue: Yes ]
  • Non relapse mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2014 (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


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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 identifier: NCT00615589

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.
Principal Investigator: Attaphol Pawarode, MD University of Michigan Dept. of Internal Medicine
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center Identifier: NCT00615589     History of Changes
Other Study ID Numbers: umcc 2007.074, HUM00014029
Study First Received: January 22, 2008
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Leukemia, Plasma Cell
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Fludarabine phosphate
Alkylating Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 24, 2014