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Study Evaluating AMG 424 in Subjects With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445663
Recruitment Status : Active, not recruiting
First Posted : February 26, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE February 1, 2018
First Posted Date  ICMJE February 26, 2018
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date December 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • Subject incidence of treatment emergent and treatment related adverse events as assessed by CTCAE version 4.0 [ Time Frame: 12 Months ]
    Measure of Safety
  • Subject incidence of dose limiting toxicities (DLTs) [ Time Frame: 28 Days ]
    Measure of Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03445663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • Anti-tumor activity [ Time Frame: 48 Months ]
    Efficacy parameter measured by IMWG response criteria
  • Duration of Response [ Time Frame: 48 Months ]
    Measure of Response
  • Maximum concentration (Cmax) of AMG 424 [ Time Frame: 12 Weeks ]
    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
  • Minimum concentration (Cmin) of AMG 424 [ Time Frame: 12 Weeks ]
    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
  • Time of maximum concentration (Tmax) of AMG 424 [ Time Frame: 12 Weeks ]
    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
  • Area under the concentration-time curve (AUC) of AMG 424 [ Time Frame: 12 Weeks ]
    Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
  • Time to progression [ Time Frame: 48 Months ]
    Measure of Response
  • Progression-Free Survival [ Time Frame: 48 Months ]
    Measure of Response
  • Overall Survival [ Time Frame: 48 Months ]
    Measure of Response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating AMG 424 in Subjects With Multiple Myeloma
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/ Refractory Multiple Myeloma
Intervention  ICMJE Drug: AMG 424
Subjects will receive IV infusions of AMG 424
Study Arms  ICMJE Experimental: AMG 424
Comparison of different dosages of AMG 424
Intervention: Drug: AMG 424
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 2, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2018)
120
Estimated Study Completion Date  ICMJE December 28, 2022
Estimated Primary Completion Date December 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03445663
Other Study ID Numbers  ICMJE 20160445
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP