Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14) (NCT01745640) | Clinical Trial Compass
CompletedPhase 2
Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14)
France63 participantsStarted 2012-01
Plain-language summary
The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or translocation (4;14)
Who can participate
Age range
19 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:
* Able to understand and voluntarily sign an informed consent form
* Age \>18 years
* Life expectancy \> 6 months.
* Patients must have a Symptomatic and Progressive MM
* Patients must have a clearly detectable and quantifiable monoclonal M-component value
* Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
* Adequate bone marrow function, with no transfusion within 5 days prior to treatment.
* Adequate organ function
* Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment.
* Able to take antithrombotic medicines
* Subjects affiliated with an appropriate social security system.
* Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug .
* Female subjects of childbearing potential (FCBP) (\*) must:
Understand the potential teratogenic risk of the treatment and take the relative precaution mentioned in the protocol, in the Pomalidomide information sheet Agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation
* For female NOT of childbearing potential, pomalidomide is contraindicated unless the exceptions mentioned in the protocol
* Understand the hazards and necessary precautions associated with the use of pomalidomide
* Male subjects must:
* Understand the potential teratogenic risk and take the relative precaution mentioned in the protocol, in…
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
Time to disease progression (from the date of the first dose to the date of the first observation of disease progression)
Timeframe: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months ).