Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
NCT ID: NCT00804947
Last Updated: 2008-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2005-09-30
2010-03-31
Brief Summary
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Detailed Description
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Secondary Graft kinetics (time to neutrophil and platelet recovery after ASCT) 2.Analyze the presence of transplant-related complications (infections, sinusoidal occlusive syndrome and others) 3.Analyze prognostic factors for engraftment, remission rate, relapse risk, disease-free and overall survival after ASCT
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous busulfan and melphalan
Intravenous busulfan and melphalan
BU is administered intravenously at a dose of 3.2 mg/kg over three hours once a day on days -5 to -3 (total dose 9.6 mg/kg), followed by MEL at a dose of 140 mg/m2 on day -2. After one day of rest, progenitor cells are infused on day 0.
Interventions
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Intravenous busulfan and melphalan
BU is administered intravenously at a dose of 3.2 mg/kg over three hours once a day on days -5 to -3 (total dose 9.6 mg/kg), followed by MEL at a dose of 140 mg/m2 on day -2. After one day of rest, progenitor cells are infused on day 0.
Eligibility Criteria
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Inclusion Criteria
* Male or female subject age \>= 70 years
* The subject has received at least one previous line of therapy including:
* Front-line treatment with VBMCP/VBAD or VAD or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide
* The subject has given voluntary written informed consent
Exclusion Criteria
* ECOG satus \>=2
* Left ventricular ejection fraction \<40%
* DLCO and FVC \<39% theoretical value
* Abnormal liver function(total bilirubin \> 2 mg/dL and/or ALT or AST \> 3 x ULN)
* Serum creatinine at transplant \>1.6 mg/dL and/or creatinine clearance \< 65 mL/minute
* Subject has an active systemic infection requiring treatment
* Subject had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias
* Subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol
* Subject is known to be immunodeficiency virus (HIV)-positive
* Subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment
* If female, the subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women
18 Years
70 Years
ALL
No
Sponsors
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Fundacion Para La Investigacion Hospital La Fe
OTHER
Responsible Party
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Hematology Service. Hospital La Fe. Valencia, Spain
Principal Investigators
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Miguel A Sanz, MD
Role: STUDY_DIRECTOR
S: de Hematología. Hospital La Fe, Valencia. Spain
Locations
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Hospital Insular Canarias
Las Palmas de Gran Canaria, Las Palmas, Spain
H La Princesa
Madrid, Madrid, Spain
H. 12 de Octubre
Madrid, Madrid, Spain
S. de Hematología. Hospital La Fe
Valencia, Valencia, Spain
Hospital Clínico
Valencia, Valencia, Spain
Hospital Dr. Peset
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Juan D González, MD
Role: primary
Adrián Alegre, MD
Role: primary
Juan J Lahuerta, MD
Role: primary
Carlos Solano, MD
Role: primary
Paz Ribas, MD
Role: primary
References
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Blanes M, Lahuerta JJ, Gonzalez JD, Ribas P, Solano C, Alegre A, Blade J, San Miguel JF, Sanz MA, de la Rubia J. Intravenous busulfan and melphalan as a conditioning regimen for autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: a matched comparison to a melphalan-only approach. Biol Blood Marrow Transplant. 2013 Jan;19(1):69-74. doi: 10.1016/j.bbmt.2012.08.009. Epub 2012 Aug 13.
Other Identifiers
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BuMel-MM
Identifier Type: -
Identifier Source: org_study_id