Overview

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