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

March 3, 2016 updated by: University of Michigan Rogel Cancer Center

Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan,Department of Internal Med. Hematology- Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Year
Percentage of Patients With Treatment Related Mortality (TRM)
Time Frame: 100 days, one-year
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
100 days, 2 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • umcc 2007.074
  • HUM00014029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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