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Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
This study is currently recruiting participants.
Verified by Fundacion Para La Investigacion Hospital La Fe, December 2008
Sponsored by: Fundacion Para La Investigacion Hospital La Fe
Information provided by: Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier: NCT00804947
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Intravenous busulfan and melphalan
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Melphalan Melphalan hydrochloride Sarcolysin Busulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan

Further study details as provided by Fundacion Para La Investigacion Hospital La Fe:

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. [ Time Frame: Within the first three months after transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival [ Time Frame: Up to 5 years after transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2005
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intravenous busulfan and melphalan: Experimental 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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804947

Contacts
Contact: Javier de la Rubia, MD 34963862746 delarubia_jav@gva.es
Contact: Guillermo Sanz, MD 34963862746 sanz_gui@gva.es

Locations
Spain
H. 12 de Octubre Recruiting
Madrid, Spain
Contact: Juan J Lahuerta, MD         jjlahuerta@terra.es    
Principal Investigator: Juan J Lahuerta, MD            
H La Princesa Recruiting
Madrid, Spain
Contact: Adrián Alegre, MD         Adrian.Alegre@telefonica.net    
Principal Investigator: Adrián Alegre, MD            
S. de Hematología. Hospital La Fe Recruiting
Valencia, Spain, 46009
Principal Investigator: Javier de la Rubia, MD            
Sub-Investigator: Guillermo Sanz, MD            
Sub-Investigator: Isidro Jarque, MD            
Hospital Dr. Peset Recruiting
Valencia, Spain
Contact: Paz Ribas, MD         ribas_paz@gva.es    
Principal Investigator: Paz Ribas, MD            
Hospital Clínico Recruiting
Valencia, Spain
Contact: Carlos Solano, MD         carlos.solano@uv.es    
Principal Investigator: Carlos Solano, MD            
Spain, Las Palmas
Hospital Insular Canarias Recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Contact: Juan D González, MD         jdgonsan@gobiernodecanarias.org    
Principal Investigator: Juan D González, MD            
Sponsors and Collaborators
Fundacion Para La Investigacion Hospital La Fe
Investigators
Study Director: Miguel A Sanz, MD S: de Hematología. Hospital La Fe, Valencia. Spain
  More Information

Responsible Party: Hematology Service. Hospital La Fe. Valencia, Spain ( Javier de la Rubia )
Study ID Numbers: BuMel-MM
Study First Received: December 5, 2008
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00804947  
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion Para La Investigacion Hospital La Fe:
Autologous transplantation
Multiple Myeloma
Intravenous Busulfan

Study placed in the following topic categories:
Melphalan
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Busulfan
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009