Trial Title:
Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
NCT ID:
NCT00804947
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Melphalan
Busulfan
Conditions: Keywords:
Autologous transplantation
Multiple Myeloma
Intravenous Busulfan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Intravenous busulfan and melphalan
Description:
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.
Arm group label:
Intravenous busulfan and melphalan
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
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Insular Canarias
Address:
City:
Las Palmas de Gran Canaria
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juan D González, MD
Email:
jdgonsan@gobiernodecanarias.org
Investigator:
Last name:
Juan D González, MD
Email:
Principal Investigator
Facility:
Name:
H La Princesa
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Adrián Alegre, MD
Email:
Adrian.Alegre@telefonica.net
Investigator:
Last name:
Adrián Alegre, MD
Email:
Principal Investigator
Facility:
Name:
H. 12 de Octubre
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juan J Lahuerta, MD
Email:
jjlahuerta@terra.es
Investigator:
Last name:
Juan J Lahuerta, MD
Email:
Principal Investigator
Facility:
Name:
S. de Hematología. Hospital La Fe
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Javier de la Rubia, MD
Email:
Principal Investigator
Investigator:
Last name:
Guillermo Sanz, MD
Email:
Sub-Investigator
Investigator:
Last name:
Isidro Jarque, MD
Email:
Sub-Investigator
Facility:
Name:
Hospital Clínico
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Carlos Solano, MD
Email:
carlos.solano@uv.es
Investigator:
Last name:
Carlos Solano, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Dr. Peset
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Paz Ribas, MD
Email:
ribas_paz@gva.es
Investigator:
Last name:
Paz Ribas, MD
Email:
Principal Investigator
Start date:
September 2005
Completion date:
March 2010
Lead sponsor:
Agency:
Fundacion Para La Investigacion Hospital La Fe
Agency class:
Other
Source:
Fundacion Para La Investigacion Hospital La Fe
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00804947
