Status:
TERMINATED
Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Multiple Myeloma
Plasma Cell Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 (au...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00615589
Start Date
February 1 2008
End Date
January 1 2013
Last Update
April 4 2016
Active Locations (1)
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1
University of Michigan,Department of Internal Med. Hematology- Oncology
Ann Arbor, Michigan, United States, 48109