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Status unknownNCT00804947Updated Dec 9, 2008

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

A Phase 2 interventional study of Intravenous busulfan and melphalan in Multiple Myeloma, sponsored by Fundacion Para La Investigacion Hospital La Fe. Status unknown at 6 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-12-09.

Sponsored by Fundacion Para La Investigacion Hospital La Fe · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Multiple Myeloma

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Keywords

  • Autologous transplantation
  • Multiple Myeloma
  • Intravenous Busulfan
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 50 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Fundacion Para La Investigacion Hospital La Fe is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Intravenous busulfan and melphalan

    Drug: Intravenous busulfan and melphalan

Interventions

  • DrugIntravenous 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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

6 of 6 sites recruiting
  • Hospital Insular Canarias
    Las Palmas de Gran Canaria, Las Palmas, Spain
    Recruiting
  • H La Princesa
    Madrid, Spain
    Recruiting
  • H. 12 de Octubre
    Madrid, Spain
    • Juan J Lahuerta, MD · Contact · jjlahuerta@terra.es
    • Juan J Lahuerta, MD · Principal investigator
    Recruiting
  • S. de Hematología. Hospital La Fe
    Valencia, 46009, Spain
    • Javier de la Rubia, MD · Principal investigator
    • Guillermo Sanz, MD · Sub investigator
    • Isidro Jarque, MD · Sub investigator
    Recruiting
  • Hospital Clínico
    Valencia, Spain
    Recruiting
  • Hospital Dr. Peset
    Valencia, Spain
    • Paz Ribas, MD · Contact · ribas_paz@gva.es
    • Paz Ribas, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Blanes M, Lahuerta JJ, Gonzalez JD, Ribas P, Solano C, Alegre A, Blade J, San Miguel JF, Sanz MA, de la Rubia J. Intravenous busulfan and melphalan as a conditioning regimen for autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: a matched comparison to a melphalan-only approach. Biol Blood Marrow Transplant. 2013 Jan;19(1):69-74. doi: 10.1016/j.bbmt.2012.08.009. Epub 2012 Aug 13. PubMed 22897964 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00804947
Lead sponsor
Fundacion Para La Investigacion Hospital La Fe
First posted
Dec 9, 2008
Start date
Sep 2005
Primary completion
Mar 2010 (estimated)
Completion
Mar 2010 (estimated)
Last update
Dec 9, 2008

Study contacts

Javier de la Rubia, MD
Contact
delarubia_jav@gva.es
34963862746
Guillermo Sanz, MD
Contact
sanz_gui@gva.es
34963862746
Miguel A Sanz, MD
study director · S: de Hematología. Hospital La Fe, Valencia. Spain

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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