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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00804947
• Other study ID #: BuMel-MM
• Status: Recruiting
• Phase: Phase 2
• First received: December 5, 2008
• Last updated: December 8, 2008
• Start date: September 2005
• Est. completion date: March 2010

Study information

• Verified date: December 2008
• Source: Fundacion Para La Investigacion Hospital La Fe
• Contact: Javier de la Rubia, MD
• Phone: 34963862746
• Email: delarubia_jav[@]gva.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Intravenous 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.

Locations

Country	Name	City	State
Spain	Hospital Insular Canarias	Las Palmas de Gran Canaria	Las Palmas
Spain	H La Princesa	Madrid
Spain	H. 12 de Octubre	Madrid
Spain	Hospital Clínico	Valencia
Spain	Hospital Dr. Peset	Valencia
Spain	S. de Hematología. Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Para La Investigacion Hospital La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes