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

Phase 2
18 Years
70 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

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

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.

Outcome Time Frame:

Within the first three months after transplant

Safety Issue:


Principal Investigator

Miguel A Sanz, MD

Investigator Role:

Study Director

Investigator Affiliation:

S: de Hematología. Hospital La Fe, Valencia. Spain


Spain: Ethics Committee

Study ID:




Start Date:

September 2005

Completion Date:

March 2010

Related Keywords:

  • Multiple Myeloma
  • Autologous transplantation
  • Multiple Myeloma
  • Intravenous Busulfan
  • Multiple Myeloma
  • Neoplasms, Plasma Cell