AMG-424: This study is trying to understand how safe and well tolerated a new targeted cancer treatment is in patients with multiple myeloma that have got worse or not responded to earlier treatment(s)A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 424 in Subjects With Multiple Myeloma

Exclusion

• Known central nervous system involvement by multiple myeloma

• Previously received allogeneic stem cell transplant and one or more of the following:

  • received the transplant < 6 months prior to study Day 1
  • received immunosuppressive therapy < 3 months prior to study Day 1
  • any active acute graft versus host disease (GvHD), grade 2- 4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
  • any systemic therapy against GvHD < 2 weeks prior to study Day 1
• Autologous stem cell transplantation less than 90 days prior to study day 1
• Multiple myeloma with IgM subtype
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Evidence of primary or secondary plasma cell leukemia at the time of screening
• Waldenstrom's macroglobulinemia
• Amyloidosis
• Dexamethasone at cumulative doses of greater than 160 mg or equivalent <3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable
• Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study Day 1
• Treatment with a therapeutic antibody targeting CD38 < 12 weeks prior to study Day 1
• Systemic radiation therapy or major surgery < 28 days prior to study Day 1 as well as focal radiotherapy < 14 days prior to study Day 1.
• Major surgery within 28 days prior to study Day 1