Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14) (IFM2010-02)

List of Key inclusion criteria:

• Must be able to understand and voluntarily sign an informed consent form
• Must be able to adhere to the study visit schedule and other protocol requirements
• Age >18 years
• Life expectancy > 6 months.
• Patients must have a Symptomatic and Progressive MM, as defined by the IMWG Patients must have had lenalidomide therapy as a previous line of therapy as one of the following: Either at front line or at relapse Either as monotherapy or in combination Independent of response obtained with lenalidomide
• Patients must have a clearly detectable and quantifiable monoclonal M-component value
• Eastern Cooperative Oncology Group (ECOG) 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 .
• Agree never to give the study medication to another person and to return any unused capsules to the investigator at the end of treatment.
• 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 the Pomalidomide information sheet .

List of Key Exclusion criteria :

• Patient that will require allogeneic or autologous transplantation following pomalidomide dexamethasone treatment while in the same course.
• Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
• Pregnant or breast feeding females
• Use of any other experimental drug or therapy within 15 days of screening.
• Patients with renal failure that require dialysis and patients with creatinine clearance < 50 mL/min
• Known positive for HIV or active infectious hepatitis type B or C.
• Patients with non-secretory MM (non measurable) Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥3 years. Excepted those mentioned in the protocol.
• Prior local irradiation within two weeks before screening
• Evidence of central nervous system (CNS) involvement
• Any >grade 2 toxicity unresolved
• Peripheral neuropathy > Grade 2
• Known Hypersensitivity to Thalidomide, Lenalidomide
• Ongoing active infection, especially ongoing pneumonitis
• Ongoing Cardiac dysfunction
• Inability or unwillingness to comply with birth control requirements
• Unable to take antithrombotic medicines at study entry
• Unable to take dexamethasone at study entry
• Refusal to participate in the study Persons protected by a legal regime (guardianship, trusteeship)