Multiple Myeloma
Conditions
Keywords
Autologous transplantation, Multiple Myeloma, Intravenous Busulfan
Brief 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
Interventions
DRUGIntravenous 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.
Sponsors
Fundacion Para La Investigacion Hospital La Fe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen. | Within the first three months after transplant |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival | Up to 5 years after transplant |
Countries
Spain
Contacts
Primary ContactJavier de la Rubia, MD
Backup ContactGuillermo Sanz, MD
Outcome results
None listed