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Relapsed/ Refractory Multiple MyelomaPhase 1NCT03445663

Study Evaluating AMG 424 in Subjects With Multiple Myeloma

A Phase 1 study testing AMG 424 in people with Relapsed/ Refractory Multiple Myeloma, run by Xencor, Inc. at 8 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/ Refractory Multiple Myeloma
What is being tested?
AMG 424
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
8 sitesin 2 countries
Study dates
31 Jul 2018to 19 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States6 sites

  • Research Site

    Charlotte, North Carolina, 28204

  • Research Site

    Cleveland, Ohio, 44195

  • Research Site

    Milwaukee, Wisconsin, 53226

  • Research Site

    San Francisco, California, 94143

  • Research Site

    Seattle, Washington, 98104

  • Research Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Australia2 sites

  • Research Site

    Camperdown, New South Wales, 2050

  • Research Site

    Fitzroy, Victoria, 3065

Other trials in Australia

About this study

Official 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

A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.

Read the detailed description

Part 1 of the study is dose evaluating and aimed at assessing the safety and tolerability of AMG 424 while determining the maximum tolerated dose (MTD) and/or biologically active dose in subjects with relapsed/ refractory multiple myeloma.

Part 2 of the study will further evaluate safety and tolerability of the AMG 424 MTD dose determined in Part 1, in groups of subjects with relapsed/ refractory multiple myeloma that include those with high or low cytogenetic risk.

Being tested
AMG 424
Keywords
Relapsed/ Refractory Multiple Myeloma, Multiple Myeloma, Oncology/Hematology, Immunotherapy
Medical subject headings
Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 424Drug

    Subjects will receive IV infusions of AMG 424

Study groups in NCT03445663
Study groupRoleWhat they receive
AMG 424ExperimentalComparison of different dosages of AMG 424
Receives: Drug: AMG 424

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject incidence of treatment emergent and treatment related adverse events as assessed by CTCAE version 4.0

    Measure of Safety

    Measured: 12 Months

  2. Subject incidence of dose limiting toxicities (DLTs)

    Measure of Safety

    Measured: 28 Days

Secondary outcomes (9)

  1. Anti-tumor activity

    Efficacy parameter measured by IMWG response criteria

    Measured: 48 Months

  2. Duration of Response

    Measure of Response

    Measured: 48 Months

  3. Maximum concentration (Cmax) of AMG 424

    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424

    Measured: 12 Weeks

  4. Minimum concentration (Cmin) of AMG 424

    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424

    Measured: 12 Weeks

  5. Time of maximum concentration (Tmax) of AMG 424

    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424

    Measured: 12 Weeks

  6. Area under the concentration-time curve (AUC) of AMG 424

    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424

    Measured: 12 Weeks

  7. Time to progression

    Measure of Response

    Measured: 48 Months

  8. Progression-Free Survival

    Measure of Response

    Measured: 48 Months

  9. Overall Survival

    Measure of Response

    Measured: 48 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start31 Jul 2018
  3. Primary completion19 Jun 2020
  4. Study completion19 Jun 2020

Why it stopped: Previous sponsor business decision not to proceed with the AMG 424 asset.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03445663
Sponsor's protocol ID
20160445
Status last verified
Mar 2023
First submitted
1 Feb 2018
Last updated
7 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 424 in people with Relapsed/ Refractory Multiple Myeloma, run by Xencor, Inc. at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Previous sponsor business decision not to proceed with the AMG 424 asset.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject incidence of treatment emergent and treatment related adverse events as assessed by CTCAE version 4.0 (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03445663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.

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