Ensayos clínicos

Inclusion Criteria: 

• Have enrolled in the MMRF002 Molecular Profiling Protocol (NCT02884102) “companion’ protocol and have a report that is less than 120 days.
• ≥ 18 years of age.
• Willing to consent to the assigned Sub-Protocol.
• Patient meets all entry criteria for the assigned Sub-Protocol.
• High risk patients with relapsed refractory multiple myeloma (RRMM), who have:
  • received at least one prior but no more than 3 prior therapies;
  • exposed to both a PI and an IMiD;
  • had early relapse after initial treatment. Early relapse is defined by at least one of the following: (Relapse is defined as the IMWG uniform response criteria (Kumar et al, 2016);
  • Within 3 years of initiation of induction chemotherapy for post ASCT followed by maintenance, or 18 months if unmaintained after ASCT;
  • Within 18 months of initial non-ASCT based therapy.
• Patients must have progressed after their most recent treatment and require therapy for myeloma.
• The following laboratory values obtained ≤ 14 days prior to registration:
  • ANC ≥ 1000/ul;
  • Hgb ≥ 8 g/dl;
  • PLT ≥ 75,000/ul (Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days prior to study drug dosing for any dosing day);
  • Total bilirubin < 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be ≤ 2.0 mg/dL;
  • AST < 3 x ULN;
  • Creatinine Clearance ≥ 30 mL/min by Cockroft Gault Equation.
• Measurable disease of MM as defined by at least ONE of the following:
  • Serum monoclonal protein ≥ 0.5g by protein electrophoresis;
  • ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis;
  • Serum immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio;
  • Monoclonal bone marrow plasmacytosis ≥30% (evaluable disease).
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
• Willingness to return to enrolling institution for follow-up.
• Disease free of prior malignancies for ≥ 3 year with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma “insitu” of the cervix or breast, or prostate cancer not requiring therapy.
• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
• All study participants must be willing to be registered into the mandatory pomalidomide (POMALYST®) Risk Evaluation and Mitigation Strategy (REMS®) program and be willing and able to comply with the requirements of the POMALYST REMS® program.
• Females of reproductive potential* must be willing to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program.
• Ability to understand the purpose and risks of the study and provide signed and dated informed consent form (ICF) and authorization to use protected health information.

*Female of reproductive potential is any sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal (not having menstrual cycles due to cancer therapy does not rule out childbearing potential) for at least 24 consecutive months.