Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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 or disease||Intervention/treatment||Phase|
|Multiple Myeloma Plasma Cell Leukemia||Drug: Fludarabine/Busulfan x 4 days Procedure: stem cell transplant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
U.S. FDA Resources
Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Drug: Fludarabine/Busulfan x 4 days
Procedure: stem cell transplant
The Fludarabine shall be administered prior to the Busulfan each day.
Allogeneic, peripheral blood stem cell transplant
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615589
|United States, Michigan|
|University of Michigan,Department of Internal Med. Hematology- Oncology|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Attaphol Pawarode, MD||University of Michigan Dept. of Internal Medicine|