IPD in RRMM Characterized with Genomic Abnormalities of Adverse Prognostic

Inclusion Criteria

• •1. Male or female patients 18 years or older.
• •2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• •3. Life expectancy \> 3 months.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
• •5. Presence - at diagnosis or at relapse - of one of the following adverse genomic abnormalities determined using Interphase fluorescence in situ hybridization and Single nucleotide polymorphism (FISH/SNP) techniques at a significant rate validated centrally by Pr AVET - LOISEAU:
• •* deletion 17p
• •* and/ or translocation (4; 14)
• •6. Must have an RRMM and have received a Lenalidomide line of treatment
• •7. Must have a Progressive Multiple Myeloma (MM) according to IMWG consensus recommendations for multiple myeloma treatment response criteria (DURIE 2007, RAJKUMAR 2011) :
• •* Increase of 25% from lowest response value in any one of the following:
• •* Serum M-component (absolute increase must be ≥ 0.5 g/dL),
• •* Urine M-component (absolute increase must be ≥ 200 mg/24 hours),
• •* Only in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC (Free Light-Chain) levels (absolute increase must be \>10 mg/dL)
• •* Bone marrow plasma cell percentage: the absolute percentage must be \>10%
• •* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
• •* Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC (Plasma Cell) proliferative disorder
• •8. Must have a measurable disease as defined by the following:
• •* IgG (immunoglobulin G) and IgA (immunoglobulin A) (serum M-component \> 5g/l)
• •* IgD (immunoglobulin D) (serum M-component \> 0.5g/l)
• •* Light chain (Bence Jones \> 200mg/24h)
• •* For MM without measurable serum or urine M protein, involved FLC ≥100 mg/l and FLC abnormal ratio.
• •9. Patients must meet the following clinical laboratory criteria:
• •* Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
• •* Total bilirubin ≤1.5 x the upper limit of the normal range (ULN).
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
• •* Calculated creatinine clearance ≥ 30 mL/min MDRD (Modification of Diet in Renal Disease) formula should be used for calculating creatinine clearance values: http://mdrd.com/
• •10. Able to undergo antithrombotic prophylactic treatment. HBPM (low weight heparin) is preferred. In case of anti-Vitamin K Agent, INR (international normalized ratio) must be used
• •11. Female patients who:
• •* Have been postmenopausal for at least 2 years before the screening visit, OR
• •* Are surgically sterile, OR
• •* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
• •* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
• •Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
• •* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
• •* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
• •12. Patients agree:
• •* not to share study medication with any other person and to return all unused study drugs to the investigator.
• •* to abstain from donating blood while taking the study drug therapy and for one week following discontinuation of the study drug therapy.
• •13. Must be able to adhere to the study visit schedule and other protocol requirements including the pregnancy prevention program as detailed in section 13.4 of protocol
• •14. Affiliated with an appropriate social security system.