Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Re… (NCT00804947) | Clinical Trial Compass
UnknownPhase 2
Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
Spain50 participantsStarted 2005-09
Plain-language summary
Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: Within the first three months after transplant
Trial details
NCT IDNCT00804947
SponsorFundacion Para La Investigacion Hospital La Fe