Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• •Histologically or cytologically confirmed multiple myeloma
• •Prior treatment with or intolerance to proteasome inhibitor and immunomodulator
• •Bone marrow biopsy within 28 days of study drug infusion demonstrating at least 5% plasma cell involvement
• •Progressive disease defined by any of following:
• •25% increase in serum M-protein from lowest response value during (or after) last therapy and/or absolute increase in serum M-protein of \> or equal to 0.5 g/dL; 25% increase in urine M-protein from lowest response value during (or after) last therapy and/or absolute increase in urine M-protein of \> or equal to 200 mg/24h; 25% increase in bone marrow plasma cell percentage from lowest response value during (or after) last therapy - absolute bone marrow plasma cell percentage must be \> or equal to 10% unless prior complete response when absolute bone marrow plasma cell percentage must be \> or equal to 5%; 25% increase in serum FLC level from the lowest response value during (or after) last therapy - the absolute increase must be \> 10 mg/dL; new onset hypercalcemia \> 11.5 mg/dL
• •Measurable disease defined by any of following: Serum M-protein \> 1 g/dL; Urine M-protein \> 200 mg/24h; Serum free light chain (FLC) assay: involved FLC level \> or equal to 10 mg/dL provided serum FLC ratio is abnormal; subjects who are non-secretors will be considered on a case-by-case basis
• •Eastern Cooperative Oncology Group performance status of 0 to 2
• •Life expectancy of at least 6 months
• •Have initiative and means to be compliant with protocol and within geographical proximity to make required study visits as judged by Investigator
• •Subject or legal representative has ability to read, understand and provide written informed consent for study related procedures
• •Women of childbearing potential must have negative pregnancy test within 24 hours of enrollment
• •Women of childbearing potential and men who are able to father a child, must agree to use an effective contraception method during study and for 12 months following study drug administration