EUCTR2011-002081-20-FRActive, not recruitingNot Applicable
A Multicenter Open label Phase II study of Pomalidomide and Dexamethasone in Progressive Relapsed or Refractory Multiple Myeloma patients with deletion 17p or translocation (4;14) Adverse Karyotypic Abnormalities. IFM 2010-02 - IFM 2010-02 -POMALIDOMIDE AND DEXAMETHASONE PHASE II MYELOME
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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 < 50 mL/min
- •6.Known positive for HIV or active infectious hepatitis type B or C.
- •7.Patients with non-secretory MM (non measurable)
- •8. Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for =3 years.9.Prior local irradiation within two weeks before screening
- •10.Evidence of central nervous system (CNS) involvement
- •11.Any >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)
Investigators
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