Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Pomalidomide; Dexamethasone
Intervention description: Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle; Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
Intervention MeSH terms: Dexamethasone; Pomalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 682.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Relapsed Multiple Myeloma; Relapsed and refractory Multiple Myeloma; Pomalidomide; Dexamethasone

Summary:

      The primary purpose of the study is to evaluate the safety and efficacy and to generate PK
      and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients
      with refractory or relapsed and refractory multiple myeloma.

      The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment
      phase and a Follow-up phase which starts within 28 days of discontinuation from study
      treatment, every 3 months for up to 5 years.

      In addition, the collection of steady-state PK data from a large population will enable
      robust population PK and assess Pomalidomide exposure response analyses.

      The exploratory objectives of the study are to investigate potential markers predictive of
      POM response or resistance and pharmacodynamic markers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.

          -  Patients must have documented diagnosis of Multiple Myeloma and have measurable
             disease.

          -  Patients must have undergone prior treatment with ≥ 2 treatments lines, of
             anti-myeloma therapy.

          -  Patients must have either refractory or relapsed and refractory disease.

          -  Patients must have received at least 2 consecutive cycles of prior treatment that
             include lenalidomide and bortezomib, either alone or in combination regimens.

          -  Patients must have received adequate alkylator therapy

        Exclusion Criteria:

          -  Prior history of malignancies, other than Multiple Myeloma.

          -  Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide
             or dexamethasone.

          -  Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem
             cell transplant.

          -  Patients who are planning for or who are eligible for stem cell transplant.

          -  Patients who received major surgery and any anti-myeloma drug therapy within the last
             14 days of starting study treatment.

          -  Patients with a current disease that can interfere with protocol procedures or study
             treatment.

          -  Patients unable or unwilling to undergo antithrombotic prophylactic treatment.

          -  Pregnant or breastfeeding females.