Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
This trial is active, not recruiting.
|Conditions||multiple myeloma, plasma cell leukemia|
|Treatments||fludarabine/busulfan x 4 days, stem cell transplant|
|Sponsor||University of Michigan Cancer Center|
|Collaborator||Otsuka Pharmaceutical Development & Commercialization, Inc.|
|Start date||February 2008|
|End date||June 2014|
|Trial size||40 participants|
|Trial identifier||NCT00615589, HUM00014029, umcc 2007.074|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
overall survival, one year from the time of transplant
time frame: one-year
Progression free survival
time frame: one-year
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
Male or female participants from 18 years up to 70 years old.
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
|Official title||Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen|
|Principal investigator||Attaphol Pawarode, MD|
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