A Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

Exclusion Criteria

• •1\. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women;
• •Patients who are eligible for stem cell transplant.
• •Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last hLL1-dox infusion;
• •Prior local radiotherapy within 14 days; chemotherapy or kyphoplasty within 21 days, immunotherapy, plasmapheresis, or major surgery within 28 days; prior stem cell transplant within 12 weeks.
• •Must have no persistent ≥ Grade 2 toxicity from prior treatments;
• •Prior treatment with any other therapeutic agents for MM or investigational agents within 4 weeks, unless off study, and agreed by Sponsor;
• •A history of allergic or adverse reactions to anthracycline/anthracenedione agents;
• •Cumulative life-time anthracycline/anthracenedione exposure exceeding 300 mg/m2 (including daunorubicin, idarubicin, epirubicin or mitoxantrone);
• •Known to be HIV positive, or any prior hepatitis B or C infection;
• •Any history of clinically significant autoimmune disease (e.g., collagen vascular disorders, autoimmune hepatitis, Coombs positive anemia/thrombocytopenia, etc.)
• •Prior history of mediastinal or pericardial external beam radiation therapy.
• •Prior history of treatment with trastuzumab, unless discussed with and agreed to by Medical Monitor.
• •Systemic infection or requiring anti-infectives within 7 days before first dose of study drug;
• •Substance abuse or other concurrent medical conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.