Clinical trial NCT00804947: Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
Official title: Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Autologous transplantation
Multiple Myeloma
Intravenous Busulfan
Lead sponsor: Fundacion Para La Investigacion Hospital La Fe
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.
timeFrame: Within the first three months after transplant
Secondary outcomes:
measure: Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival
timeFrame: Up to 5 years after transplant
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular Canarias
state: Las Palmas
city: Madrid
country: Spain
facility: H La Princesa
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Valencia
country: Spain
facility: S. de Hematología. Hospital La Fe
city: Valencia
country: Spain
facility: Hospital Clínico
city: Valencia
country: Spain
facility: Hospital Dr. Peset
Study officials:
affiliation: S: de Hematología. Hospital La Fe, Valencia. Spain
name: Miguel A Sanz, MD
role: STUDY_DIRECTOR
References:
citation: 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.