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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804947
Recruitment Status : Unknown
Verified December 2008 by Fundacion Para La Investigacion Hospital La Fe.
Recruitment status was:  Recruiting
First Posted : December 9, 2008
Last Update Posted : December 9, 2008
Information provided by:
Fundacion Para La Investigacion Hospital La Fe

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2005
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00804947

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Contact: Javier de la Rubia, MD 34963862746
Contact: Guillermo Sanz, MD 34963862746

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Hospital Insular Canarias Recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Contact: Juan D González, MD   
Principal Investigator: Juan D González, MD         
H La Princesa Recruiting
Madrid, Spain
Contact: Adrián Alegre, MD   
Principal Investigator: Adrián Alegre, MD         
H. 12 de Octubre Recruiting
Madrid, Spain
Contact: Juan J Lahuerta, MD   
Principal Investigator: Juan J Lahuerta, 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 Clínico Recruiting
Valencia, Spain
Contact: Carlos Solano, MD   
Principal Investigator: Carlos Solano, MD         
Hospital Dr. Peset Recruiting
Valencia, Spain
Contact: Paz Ribas, MD   
Principal Investigator: Paz Ribas, MD         
Sponsors and Collaborators
Fundacion Para La Investigacion Hospital La Fe
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Study Director: Miguel A Sanz, MD S: de Hematología. Hospital La Fe, Valencia. Spain
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Javier de la Rubia, Hematology Service. Hospital La Fe. Valencia, Spain Identifier: NCT00804947    
Other Study ID Numbers: BuMel-MM
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: December 9, 2008
Last Verified: December 2008
Keywords provided by Fundacion Para La Investigacion Hospital La Fe:
Autologous transplantation
Multiple Myeloma
Intravenous Busulfan
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs