Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma
|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: NCT00427765|
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : January 19, 2012
Last Update Posted : January 19, 2012
- To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma.
- To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
- To determine the disease-free and overall survival of patients receiving this preparative regimen.
- To determine the treatment-related morbidity and mortality of this combination of drugs.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Lymphoma||Drug: Busulfan Drug: Melphalan||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of High-Dose Intravenous Busulfan Plus Melphalan With Allogeneic or Autologous Marrow or Peripheral Blood Progenitor Cell Transplantation for Lymphoid Malignancies or Multiple Myeloma|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Experimental: Busulfan + Melphalan
Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
Test Dose = 32 mg/m^2 IV for 1 Day; 130 mg/m^2 IV for 4 Days
Other Name: Busulfex
70 mg/m^2 IV for 2 Days
- Average Overall Survival Time [ Time Frame: Baseline(transplantation) to disease progression or death for any reason, up to 6 years. ]Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427765
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Partow Kebriaei, MD||M.D. Anderson Cancer Center|