A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a first in human phase 1 multicenter open label study in subjects with relapsed or refractory multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Pathologically documented,multiple myeloma relapsed or refractory progressive disease after at least 3 lines of therapy for multiple myeloma.

Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g. bortezomib) and immunomodulatory drugs (e.g. lenalidomide).

• Willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).

• Measurable disease per the International Myeloma Working Group (IMWG) response criteria

• Hematological function, as follows, without transfusion support:

• Absolute neutrophil count ≥ 1.0 X 10^9/L,

• Platelet count ≥ 75 X 10^9/L (in patients with < 50% of bone marrow nucleated cells were plasma cells) or ≥ 50 X 10^9/L (in patients with ≥ 50% of bone marrow nucleated cells were plasma cells) without transfusion or growth factor support

• Hemoglobin > 8 g/dL (> 80 g/L)

• Adequate renal and hepatic function

• Left ventricular ejection fraction (LVEF) > 50%

Exclusion Criteria:

• Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study

• Autologous stem cell transplant less than 90 days prior to study day 1

• Multiple myeloma with IgM subtype

• POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis

• Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to study day

• Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II)

• A baseline ECG QTcF > 470 msec

• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1