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

Sponsor

Fundacion Para La Investigacion Hospital La Fe (Other)

Overall Status

Unknown status

CT.gov ID

NCT00804947

Collaborator

(none)

Enrollment

Locations

Arm

53.9

Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Intravenous busulfan and melphalan	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Anticipated Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous busulfan and melphalan	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.

Arm

Intervention/Treatment

Experimental: Intravenous busulfan and melphalan

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Insular Canarias	Las Palmas de Gran Canaria	Las Palmas	Spain
2	H La Princesa	Madrid		Spain
3	H. 12 de Octubre	Madrid		Spain
4	S. de Hematología. Hospital La Fe	Valencia		Spain	46009
5	Hospital Clínico	Valencia		Spain
6	Hospital Dr. Peset	Valencia		Spain