Study Evaluating AMG 424 in Subjects With Multiple Myeloma

NCT03445663 | Terminated Phase 1 FDA Drug

• 1 other identifier: 20160445
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 8

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.

Conditions

Relapsed/ Refractory Multiple Myeloma

Keywords

Relapsed/ Refractory Multiple Myeloma; Multiple Myeloma; Oncology/Hematology; Immunotherapy

Outcome Measures

Primary Outcomes (2)

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

  Measure of Safety

  12 Months

• Subject incidence of dose limiting toxicities (DLTs)

  Measure of Safety

  28 Days

Secondary Outcomes (9)

• Anti-tumor activity

  48 Months

• Duration of Response

  48 Months

• Maximum concentration (Cmax) of AMG 424

  12 Weeks

• Minimum concentration (Cmin) of AMG 424

  12 Weeks

• Time of maximum concentration (Tmax) of AMG 424

  12 Weeks

Study Arms (1)

AMG 424

EXPERIMENTAL

Comparison of different dosages of AMG 424

Drug: AMG 424

Interventions

AMG 424 DRUG

Subjects will receive IV infusions of AMG 424

AMG 424

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (8)

Research Site

San Francisco, California, 94143, United States

Location

Research Site

Charlotte, North Carolina, 28204, United States

Location

Research Site

Winston-Salem, North Carolina, 27157, United States

Location

Research Site

Cleveland, Ohio, 44195, United States

Location

Research Site

Seattle, Washington, 98104, United States

Location

Research Site

Milwaukee, Wisconsin, 53226, United States

Location

Research Site

Camperdown, New South Wales, 2050, Australia

Location

Research Site

Fitzroy, Victoria, 3065, Australia

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 26, 2018
• Study Start: July 31, 2018
• Primary Completion: June 19, 2020
• Study Completion: June 19, 2020
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

US (6); AU (2)