Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma

Inclusion Criteria

• •Willing and able to sign an informed consent Male or female, 18 years or older Confirmed diagnosis of multiple myeloma (secretory disease) by International Myeloma Working Group Diagnostic Criteria
• •Patients must meet one of the following criteria:
• •o Previously treated patients with multiple myeloma who achieved at least stable disease but who have failed to achieve a complete response (CR) after a minimum of one cytoreductive therapy for multiple myeloma and have detectable but non-progressing disease. Patients must have received at least one proteasome inhibitor (eg, bortezomib) or one immunomodulatory agent (eg, thalidomide or lenalidomide) or both.
• •Patients receiving lenalidomide as maintenance therapy may continue to receive this therapy provided that the patient has been on this maintenance therapy for a minimum of 3 months and has evidence of disease stabilization.
• •Disease stabilization will be defined as an M protein that varies ≤ 25% over the three measurements or remains under 0.5 g/dL whichever is smaller.
• •ECOG performance status 0-2 Life expectancy ≥ 3 months
• •Laboratory criteria (within 14 days of first study drug administration):
• •ANC ≥ 1000/μL
• •Platelet count ≥ 50 x 103/μL (without transfusion support within 2 weeks prior to first study drug administration)
• •Hemoglobin ≥ 8.0 g/dL
• •Serum creatinine ≤ 3 x the upper limit of normal (ULN)
• •AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN), unless due to disease.
• •Must have fully recovered from any previous cancer treatments and/or major surgery.
• •Women of childbearing potential must have a negative serum pregnancy test and agree to use effective birth control (two reliable forms of contraception) during and for at least 12 weeks after the last treatment.
• •Males must agree to use effective birth control for themselves or their partner during and for 12 weeks after the last treatment with imetelstat. For those patients receiving lenolidomide, males must use latex condom during sexual contact with women of childbearing potential even if they have undergone a successful vasectomy.