Clinical trial · Interventional
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
NCT00804947CI-TRIAL-00001829unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous busulfan and melphalan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravenous busulfan and melphalan
- interventionNames
- Drug: Intravenous busulfan and melphalan
Primary outcomes (1)
- 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.
- timeFrame
- Within the first three months after transplant
Secondary outcomes (1)
- measure
- Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival
- timeFrame
- Up to 5 years after transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBlanes 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. PMID 22897964