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

Fundacion Para La Investigacion Hospital La Fe

Status and phase

Unknown

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Intravenous busulfan and melphalan

Study type

Interventional

Funder types

Other

Identifiers

NCT00804947

BuMel-MM

Details and patient eligibility

About

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

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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