This study will determine the efficacy and toxicity profile of pomalidomide and dexamethasone in patients with adverse prognostic factors as determined using adverse karyotypic abnormalities and that are in desperate need of novel therapeutics.
Conditions
Interventions
Product Name: POMALIDOMIDE
Pharmaceutical Form: Capsule
Sponsors
CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Must be able to understand and voluntarily sign an informed consent form 2.Must be able to adhere to the study visit schedule and other protocol requirements 3. Age >18 years 4. Life expectancy > 6 months. 5. Patients must have a relapsed or refractory myeloma, with progressive disease as defined by the IMWG and must have received prior therapy with lenalidomide (at least 2 cycles, being not intolerant to lenalidomide, whatever resistant or responsive to lenalidomide) 6. Patients must have a Symptomatic and Progressive MM 7. Patients must have a clearly detectable and quantifiable monoclonal M-component value 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 9. Adequate bone marrow function, with no transfusion within 5 days prior to treatment 10. Adequate organ function 11. Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment. 12. Able to take antithrombotic medicines such as Low molecular weight heparin or Aspirin 75mg 13. Subjects affiliated with an appropriate social security system. 14. Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug . 15. Agree never to give the study medication to another person and to return any unused capsules to the investigator at the end of treatment. Only enough pomalidomide for one cycle of therapy may be dispensed with each cycle of therapy 16.Female subjects of childbearing potential (FCBP) (*) must take special precautions as described in the information letter and in the consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patient that will require allogeneic or autologous transplantation following pomalidomide dexamethasone treatment while in the same course. 2.Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation 3.Pregnant or breast feeding females 4.Use of any other experimental drug or therapy within 15 days of screening. 5.Patients with renal failure that require dialysis and patients with creatinine clairance grade 2 toxicity unresolved 12.Peripheral neuropathy > Grade 2 13.Known Hypersensitivity to Thalidomide, Lenalidomide 14.Ongoing active infection, especially ongoing pneumonytis 15.Ongoing Cardiac dysfunction 16.Inability or unwillingness to comply with birth control requirements 17.Unable to take antithrombotic medicines at study entry 18.Unable to take dexamethasone at study entry 19.Refusal to participate in the study 20.Persons protected by a legal regime (guardianship, trusteeship)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine Time to disease progression (TTP) to pomalidomide and dexamethasone in patients with deletion 17p or translocation (4;14) with relapsed or refractory myeloma;Secondary Objective: • To determine Safety of pomalidomide and dexamethasone • To determine Overall Response rate (Partial Response and better), Very Good Partial Response (VGPR) + Complete Response (CR) rate and stringent Complete Response (sCR) rate to pomalidomide and dexamethasone in MM patients • To determine Time to response and Response duration of pomalidomide and dexamethasone. • Overall Survival of pomalidomide and dexamethasone and event free survival • To determine Response and Time to disease progression with regards to cytogenetic abnormalities in the bone marrow tumor plasma cells ;Primary end point(s): •To determine Time to disease progression (TTP) to pomalidomide and dexamethasone in patients with deletion 17p or translocation (4;14) with relapsed or refractory myeloma | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To determine Safety of pomalidomide and dexamethasone •To determine Overall Response rate (Partial Response and better), Very Good Partial Response (VGPR) + Complete Response (CR) rate and stringent Complete Response (sCR) rate to pomalidomide and dexamethasone in MM patients •To determine Time to response and Response duration of pomalidomide and dexamethasone. •Overall Survival of pomalidomide and dexamethasone and event free survival •To determine Response and Time to disease progression with regards to cytogenetic abnormalities in the bone marrow tumor plasma cells | — |
Countries
France
Outcome results
None listed