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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Fundacion Para La Investigacion Hospital La Fe.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier:
NCT00804947
First received: December 5, 2008
Last updated: December 8, 2008
Last verified: December 2008
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
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

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
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. 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         
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

No publications provided by Fundacion Para La Investigacion Hospital La Fe

Additional 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
Study First Received: December 5, 2008
Last Updated: December 8, 2008
Health Authority: Spain: Ethics Committee

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
Busulfan
Melphalan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 23, 2014