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A Phase 1 Study of AMG 701 in Subjects With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03287908
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this First-in-Human Phase 1 study is to determine during the escalation part if AMG 701 given as weekly short term IV infusions is safe and tolerable followed by a dose expansion part to gain further efficacy and safety experience with AMG 701 in adult subjects with relapsed / refractory multiple myeloma. The study will be conducted in multiple sites and test increasing doses of AMG 701. The safety of subjects will be monitored by intensive assessments of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Drug: AMG 701 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 in Subjects With Multiple Myeloma
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : January 8, 2021
Estimated Study Completion Date : July 13, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: AMG 701
Comparison of different dosages of drug
Drug: AMG 701
Patients will receive IV infusions of AMG 701




Primary Outcome Measures :
  1. Subject incidence of adverse events as a Measure of Safety [ Time Frame: 48 months ]
  2. Subject incidence of dose-limiting toxicities (DLTs) as a Measure of Safety [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Anti-tumor activity [ Time Frame: 48 months ]
    Efficacy parameter measured by IMWG response criteria: stringent Complete Response (CR)

  2. Anti-tumor activity [ Time Frame: 48 months ]
    Progression-free survival

  3. Pharmacokinetic parameter of AMG 701 [ Time Frame: 12 weeks ]
    Maximum concentration (Cmax)

  4. Pharmacokinetic parameter of AMG 701 [ Time Frame: 12 weeks ]
    Time of maximum concentration (Tmax)

  5. Pharmacokinetic parameter of AMG 701 [ Time Frame: 12 weeks ]
    Area under the concentration-time curve (AUC)

  6. Anti-tumor activity [ Time Frame: 48 months ]
    Efficacy parameter measured by IMWG response criteria: CR

  7. Anti-tumor activity [ Time Frame: 48 months ]
    Efficacy parameter measured by IMWG response criteria: very good Partial Response (PR)

  8. Anti-tumor activity [ Time Frame: 48 months ]
    Efficacy parameter measured by IMWG response criteria: PR

  9. Anti-tumor activity [ Time Frame: 48 months ]
    Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple myeloma meeting the following criteria:

    • Pathologically-documented diagnosis of multiple myeloma that is relapsed or is refractory as defined by the following:

      • Relapsed after > or = 2 lines of prior therapy that must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and, where approved and available, a CD38-directed cytolytic antibody in any order during the course of treatment OR refractory to PI, IMiD, and CD38- directed cytolytic antibody,
      • Subjects who could not tolerate a PI, IMiDs, or a CD38-directed cytolytic antibody are eligible to enroll in the study.
    • Measurable disease as per IMWG response criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

Exclusion Criteria:

  • Extramedullary disease in the absence of any measurable medullary involvement
  • Known central nervous system involvement by multiple myeloma
  • 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)
  • Known history of primary plasma cell leukemia or evidence of primary or secondary plasma cell leukemia at the time of screening
  • Waldenstrom's macroglobulinemia
  • Amyloidosis
  • Treatment with systemic immune modulators including, but not limited to, nontopical systemic corticosteroids (unless the dose is ≤ 10 mg/day prednisone or equivalent), cyclosporine, and tacrolimus within 2 weeks before study day 1
  • Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study day 1 or treatment with a therapeutic antibody less than 4 weeks prior to study day 1 as well as systemic radiation therapy within 28 days prior to study day 1 or focal radiotherapy within 14 days prior to study day 1.
  • Prior treatment with a drug that targets BCMA on tumor cells or any other bi specific antibody construct or chimeric antigen receptor T cell (CAR-T) infusion for the treatment of multiple myeloma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287908


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03287908     History of Changes
Other Study ID Numbers: 20170122
2017-001997-41 ( EudraCT Number )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Amgen
Phase 1
Clinical Trial
Oncology/Hematology
Relapsed/Refractory Multiple Myeloma
Immunotherapy

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases