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

December 8, 2008 updated by: Fundacion Para La Investigacion Hospital La Fe

Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan

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

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • H. 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Juan J Lahuerta, MD
      • Madrid, Spain
      • Valencia, Spain
        • Recruiting
        • Hospital Clínico
        • Contact:
        • 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:
        • Principal Investigator:
          • Paz Ribas, MD
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Para La Investigacion Hospital La Fe

Investigators

  • Study Director: Miguel A Sanz, MD, S: de Hematología. Hospital La Fe, Valencia. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2008

Last Update Submitted That Met QC Criteria

December 8, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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