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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Fundacion Para La Investigacion Hospital La Fe.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804947
First Posted: December 9, 2008
Last Update Posted: December 9, 2008
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.
Information provided by:
Fundacion Para La Investigacion Hospital La Fe
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

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 ]

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
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00804947


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

Locations
Spain
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         
H La Princesa Recruiting
Madrid, Spain
Contact: Adrián Alegre, MD       Adrian.Alegre@telefonica.net   
Principal Investigator: Adrián Alegre, MD         
H. 12 de Octubre Recruiting
Madrid, Spain
Contact: Juan J Lahuerta, MD       jjlahuerta@terra.es   
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       carlos.solano@uv.es   
Principal Investigator: Carlos Solano, MD         
Hospital Dr. Peset Recruiting
Valencia, Spain
Contact: Paz Ribas, MD       ribas_paz@gva.es   
Principal Investigator: Paz Ribas, 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javier de la Rubia, Hematology Service. Hospital La Fe. Valencia, Spain
ClinicalTrials.gov Identifier: NCT00804947     History of Changes
Other Study ID Numbers: BuMel-MM
First Submitted: December 5, 2008
First Posted: December 9, 2008
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:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Busulfan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs


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