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 range19 Years
SexALL
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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…
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 ).