This is a first-in-human (FIH), multicenter, non-randomized, open-label, phase 1 study evaluating AMG 397 administered orally once daily for 2 consecutive days followed by 5 days break at a weekly interval, as part of a 28-day treatment cycle in adult subjects with multiple myeloma, non-Hodgkin's lymphoma, and acute myeloid leukemia.
AMG 397 administered orally once daily for 2 consecutive days followed by 5 days break at a weekly interval, as part of a 28-day treatment cycle in adult subjects with selected RR hematological malignancies
SparkCures ID | 988 |
---|---|
Trial Phase | Phase 1 |
Enrollment | 90 Patients |
Treatments | |
Trial Sponsors |
|
NCT Identifier |
|
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Criteria:
MM subjects only: Measurable disease per the IMWG response criteria, as indicated by one or more of the following: Serum M-protein ≥ 0.5 g/dL, Urine M-protein ≥ 200 mg/24 hours. For Subjects who do not meet 1 of the 2 prior criteria: Serum Free Light Chain (sFLC) ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal sFLC ratio (< 0.26 or > 1.65) as per the IMWG response criteria
Exclusion Criteria:
Please visit the ClinicalTrials.gov page for historical site information.
View Centers