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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03445663
Registration number
NCT03445663
Ethics application status
Date submitted
1/02/2018
Date registered
26/02/2018
Date last updated
7/03/2023
Titles & IDs
Public title
Study Evaluating AMG 424 in Subjects With Multiple Myeloma
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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
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Secondary ID [1]
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20160445
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed/ Refractory Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Subject incidence of treatment emergent and treatment related adverse events as assessed by CTCAE version 4.0
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Assessment method [1]
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Measure of Safety
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Timepoint [1]
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12 Months
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Primary outcome [2]
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Subject incidence of dose limiting toxicities (DLTs)
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Assessment method [2]
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Measure of Safety
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Timepoint [2]
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28 Days
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Secondary outcome [1]
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Anti-tumor activity
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Assessment method [1]
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Efficacy parameter measured by IMWG response criteria
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Timepoint [1]
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48 Months
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Measure of Response
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Timepoint [2]
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48 Months
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Secondary outcome [3]
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Maximum concentration (Cmax) of AMG 424
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Assessment method [3]
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Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
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Timepoint [3]
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12 Weeks
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Secondary outcome [4]
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Minimum concentration (Cmin) of AMG 424
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Assessment method [4]
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Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
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Timepoint [4]
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12 Weeks
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Secondary outcome [5]
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Time of maximum concentration (Tmax) of AMG 424
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Assessment method [5]
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Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
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Timepoint [5]
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12 Weeks
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Secondary outcome [6]
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Area under the concentration-time curve (AUC) of AMG 424
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Assessment method [6]
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Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
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Timepoint [6]
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12 Weeks
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Secondary outcome [7]
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Time to progression
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Assessment method [7]
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Measure of Response
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Timepoint [7]
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48 Months
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Secondary outcome [8]
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Progression-Free Survival
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Assessment method [8]
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Measure of Response
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Timepoint [8]
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48 Months
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Secondary outcome [9]
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Overall Survival
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Assessment method [9]
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Measure of Response
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Timepoint [9]
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48 Months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/06/2020
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Fitzroy
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Washington
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Country [5]
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United States of America
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State/province [5]
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Wisconsin
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Xencor, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in
subjects with relapsed/ refractory multiple myeloma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03445663
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03445663
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