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

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID: NCT02561962
Run by: Amgen
People needed: 42
Starts: 2015-11-20
Expected to finish: 2022-04-21
Last updated by the study team: 2024-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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%

You may not qualify if…

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

Where it is running

Research Site — West Hollywood, California, United States
Research Site — Boston, Massachusetts, United States
Research Site — New York, New York, United States
Research Site — Houston, Texas, United States
Research Site — Prahran, Victoria, Australia

Full record on ClinicalTrials.gov

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