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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02561962




Registration number
NCT02561962
Ethics application status
Date submitted
25/09/2015
Date registered
28/09/2015
Date last updated
11/12/2019

Titles & IDs
Public title
A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
20130314
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 224

Experimental: Dose Exploration -


Treatment: Drugs: AMG 224
AMG 224 will be given on Day 1 once every 3 weeks with dose ranging from 30 mg to 300 mg.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicities (DLTs)
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Incidence of treatment-related adverse events
Timepoint [2] 0 0
3 years
Primary outcome [3] 0 0
Incidence of treatment-emergent adverse events
Timepoint [3] 0 0
3 years
Primary outcome [4] 0 0
Number of subjects with clinically significant changes in vital signs
Timepoint [4] 0 0
3 years
Primary outcome [5] 0 0
Number of subjects with clinically significant changes in physical examinations
Timepoint [5] 0 0
3 years
Primary outcome [6] 0 0
Number of subjects with clinically significant changes in ECGs
Timepoint [6] 0 0
3 years
Primary outcome [7] 0 0
Number of subjects with clinically significant changes in clinical laboratory tests
Timepoint [7] 0 0
3 years
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax) - PK parameters for AMG 224 conjugated antibody, Total anti-BCMA antibody, and total unconjugated DM1
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Minimum observed concentration (Cmin) - PK parameters for AMG 224 conjugated antibody, Total anti-BCMA antibody, and total unconjugated DM2
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Area under the concentration-time curve (AUC) - PK parameters for AMG 224 conjugated antibody, Total anti-BCMA antibody, and total unconjugated DM3
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Clearance (CL) - PK parameters for AMG 224 conjugated antibody, Total anti-BCMA antibody, and total unconjugated DM4
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Half-life (t1/2), if feasible - PK parameters for AMG 224 conjugated antibody, Total anti-BCMA antibody, and total unconjugated DM5
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Overall response according to International Myeloma Working Group (IMWG) uniform response criteria
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Relative reduction in M-component
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Time to progression (TTP)
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
Duration of response (DOR)
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
Conversion to MRD negativity
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
Incidence of anti-AMG 224 antibody formation
Timepoint [11] 0 0
3 years

Eligibility
Key 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 IMWG response criteria

- Hematological function, as follows, without transfusion support:

- Absolute neutrophil count = 1.0 X 10 9/L,

- Platelet count = 75 X 109/L (in patients with < 50% of bone marrow nucleated cells
were plasma cells) or = 50 X 109/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%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

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

- Multiple myeloma with IgM subtype

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

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

- POEMS syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a first in human phase 1 multicenter open label study in subjects with relapsed or
refractory multiple myeloma.
Trial website
https://clinicaltrials.gov/show/NCT02561962
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications