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Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Autologous transplantation, Multiple Myeloma, Intravenous Busulfan
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Intravenous busulfan and melphalan
Type: Drug
Overall Status
Recruiting
Summary
Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
Detailed Description
Primary Efficacy and safety of the procedure in terms of number of remissions, survival, event-free survival, relapse risk, and early transplant-related mortality (up to day +100).
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
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Symptomatic multiple myeloma
- 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:
- Use of bortezomib, thalidomide or lenalidomide as front-line therapy
- 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
- Symptomatic multiple myeloma
- 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:
- Use of bortezomib, thalidomide or lenalidomide as front-line therapy
- 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
Locations
Hospital Insular Canarias
Las Palmas de Gran Canaria, Las Palmas, Spain
H La Princesa
Status: Recruiting
Contact: Juan D González, MD - jdgonsan@gobiernodecanarias.org
Madrid, Spain
H. 12 de Octubre
Status: Recruiting
Contact: Adrián Alegre, MD - Adrian.Alegre@telefonica.net
Madrid, Spain
Hospital Clínico
Status: Recruiting
Contact: Juan J Lahuerta, MD - jjlahuerta@terra.es
Valencia, Spain
Hospital Dr. Peset
Status: Recruiting
Contact: Carlos Solano, MD - carlos.solano@uv.es
Valencia, Spain
S. de Hematología. Hospital La Fe
Status: Recruiting
Contact: Paz Ribas, MD - ribas_paz@gva.es
Valencia, Spain
Status: Recruiting
Start Date
September 2005
Completion Date
March 2010
Sponsors
Fundacion Para La Investigacion Hospital La Fe
Source
Fundacion Para La Investigacion Hospital La Fe
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page