Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia (NCT01328236) | Clinical Trial Compass
UnknownPhase 2
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
China20 participantsStarted 2010-09
Plain-language summary
Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).
The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).
Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).
Who can participate
Age range
18 Years – 75 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:
* Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib
* KPS ≥ 60
* Adequate liver and renal function within 2 weeks of Screening:
* Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
* Cardiac function \> Ⅲ grade and ejection fraction \> 45%
* Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care
Exclusion Criteria:
* has taken Bortezomib
* KPS ≤ 60 scores
* mental illness
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.
1This trial combines three drugs — bortezomib, liposomal doxorubicin, and dexamethasone — for plasma cell leukemia, which is already an aggressive condition; can you walk me through what the known side effects of each of these drugs are and how they might interact when used together?
2Since this is a Phase 2 trial, the main goal is measuring how many patients respond to the treatment — not yet comparing it head-to-head against a standard therapy — does that mean there's still a lot unknown about whether this combination is better or safer than other options I might have?
3The trial's recruitment status is listed as unknown, so is this study still actively enrolling patients, and if not, are there similar or updated trials I should be looking into instead?
4Plasma cell leukemia is rare and often treated urgently — given my specific situation, would you recommend trying a proven standard treatment first, or does the severity of my diagnosis make a trial like this worth discussing sooner?
5The trial is measuring overall response rate as its main outcome — what does a 'response' actually mean in this context, and if I responded to the treatment, what would that realistically mean for my long-term outlook?
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.