- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804947
Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Javier de la Rubia, MD
- Phone Number: 34963862746
- Email: delarubia_jav@gva.es
Study Contact Backup
- Name: Guillermo Sanz, MD
- Phone Number: 34963862746
- Email: sanz_gui@gva.es
Study Locations
-
-
-
Madrid, Spain
- Recruiting
- H. 12 de Octubre
-
Contact:
- Juan J Lahuerta, MD
- Email: jjlahuerta@terra.es
-
Principal Investigator:
- Juan J Lahuerta, MD
-
Madrid, Spain
- Recruiting
- H La Princesa
-
Contact:
- Adrián Alegre, MD
- Email: Adrian.Alegre@telefonica.net
-
Principal Investigator:
- Adrián Alegre, MD
-
Valencia, Spain
- Recruiting
- Hospital Clinico
-
Contact:
- Carlos Solano, MD
- Email: carlos.solano@uv.es
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Principal Investigator:
- Carlos Solano, MD
-
Valencia, Spain, 46009
- Recruiting
- S. de Hematología. Hospital La Fe
-
Principal Investigator:
- Javier de la Rubia, MD
-
Sub-Investigator:
- Guillermo Sanz, MD
-
Sub-Investigator:
- Isidro Jarque, MD
-
Valencia, Spain
- Recruiting
- Hospital Dr. Peset
-
Contact:
- Paz Ribas, MD
- Email: ribas_paz@gva.es
-
Principal Investigator:
- Paz Ribas, MD
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spain
- Recruiting
- Hospital Insular Canarias
-
Contact:
- Juan D González, MD
- Email: jdgonsan@gobiernodecanarias.org
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Principal Investigator:
- Juan D González, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Within the first three months after transplant
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 5 years after transplant
|
Collaborators and Investigators
Investigators
- Study Director: Miguel A Sanz, MD, S: de Hematología. Hospital La Fe, Valencia. Spain
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Multiple Myeloma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
- Busulfan
Other Study ID Numbers
- BuMel-MM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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