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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03445663




Registration number
NCT03445663
Ethics application status
Date submitted
1/02/2018
Date registered
26/02/2018

Titles & IDs
Public title
Study Evaluating AMG 424 in Subjects With Multiple Myeloma
Scientific title
A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 424 in Subjects With Multiple Myeloma
Secondary ID [1] 0 0
20160445
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/ Refractory 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 424

Experimental: AMG 424 - Comparison of different dosages of AMG 424


Treatment: Drugs: AMG 424
Subjects will receive IV infusions of AMG 424
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of treatment emergent and treatment related adverse events as assessed by CTCAE version 4.0
Timepoint [1] 0 0
12 Months
Primary outcome [2] 0 0
Subject incidence of dose limiting toxicities (DLTs)
Timepoint [2] 0 0
28 Days
Secondary outcome [1] 0 0
Anti-tumor activity
Timepoint [1] 0 0
48 Months
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
48 Months
Secondary outcome [3] 0 0
Maximum concentration (Cmax) of AMG 424
Timepoint [3] 0 0
12 Weeks
Secondary outcome [4] 0 0
Minimum concentration (Cmin) of AMG 424
Timepoint [4] 0 0
12 Weeks
Secondary outcome [5] 0 0
Time of maximum concentration (Tmax) of AMG 424
Timepoint [5] 0 0
12 Weeks
Secondary outcome [6] 0 0
Area under the concentration-time curve (AUC) of AMG 424
Timepoint [6] 0 0
12 Weeks
Secondary outcome [7] 0 0
Time to progression
Timepoint [7] 0 0
48 Months
Secondary outcome [8] 0 0
Progression-Free Survival
Timepoint [8] 0 0
48 Months
Secondary outcome [9] 0 0
Overall Survival
Timepoint [9] 0 0
48 Months

Eligibility
Key inclusion criteria
* Multiple myeloma meeting the following criteria:
* Pathologically-documented diagnosis of multiple myeloma that has relapsed after at least two prior lines of therapy that must include a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and, where approved and available, anti-CD38 therapy in any order OR that is refractory to PI, IMiD, and anti-CD38 therapy.

?Subjects who could not tolerate a PI, IMiDs, or a CD38-directed therapeutic antibody due to unacceptable toxicities are eligible to enroll in the study.
* Measurable disease as per IMWG response criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known central nervous system involvement by multiple myeloma
* Previously received allogeneic stem cell transplant and one or more of the following:

* received the transplant < 6 months prior to study Day 1
* received immunosuppressive therapy < 3 months prior to study Day 1
* any active acute graft versus host disease (GvHD), grade 2- 4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
* any systemic therapy against GvHD < 2 weeks prior to study Day 1
* Autologous stem cell transplantation less than 90 days prior to study day 1
* Multiple myeloma with IgM subtype
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Evidence of primary or secondary plasma cell leukemia at the time of screening
* Waldenstrom's macroglobulinemia
* Amyloidosis
* Dexamethasone at cumulative doses of greater than 160 mg or equivalent <3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable
* Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study Day 1
* Treatment with a therapeutic antibody targeting CD38 < 12 weeks prior to study Day 1
* Systemic radiation therapy or major surgery < 28 days prior to study Day 1 as well as focal radiotherapy < 14 days prior to study Day 1.
* Major surgery within 28 days prior to study Day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/06/2020
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
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
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Xencor, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03445663