Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen

Study Overview
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Brief Summary
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Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.

Detailed Description
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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

Official Title
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Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Intravenous busulfan and melphalan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous busulfan and melphalan<br> | Drug: Intravenous busulfan and melphalan<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous transplantation, Multiple Myeloma, Intravenous Busulfan