A Multicenter, Single-Arm, Open-Label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma
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.