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

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

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 14, 2008
Results First Submitted Date  ICMJE December 3, 2014
Results First Posted Date  ICMJE December 11, 2014
Last Update Posted Date April 4, 2016
Study Start Date  ICMJE February 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
overall survival, one year from the time of transplant [ Time Frame: one-year ]
Change History Complete list of historical versions of study NCT00615589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
  • Progression free survival [ Time Frame: one-year ]
  • Treatment-related Mortality [ Time Frame: 100 days, one-year ]
  • Incidence of acute and chronic GVHD [ Time Frame: 100 days, 2 years ]
  • Non Relapse Mortality [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Official Title  ICMJE Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma
  • Plasma Cell Leukemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Flu-Bu4
Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Interventions:
  • Drug: Fludarabine/Busulfan x 4 days
  • Procedure: stem cell transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
22
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2008)
40
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00615589
Other Study ID Numbers  ICMJE umcc 2007.074
HUM00014029
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators  ICMJE
Principal Investigator: Attaphol Pawarode, MD University of Michigan Dept. of Internal Medicine
PRS Account University of Michigan Rogel Cancer Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP