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A Phase 1/2 Study of AMG 701 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03287908
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : March 19, 2020
Information provided by (Responsible Party):

Brief Summary:
The primary purpose of the phase 1 part of the study is to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, RP2D) and to confirm the safety and tolerability of the RP2D. The dose escalation part of the study will be conducted at multiple sites and test increasing doses and dosing schedules of AMG 701. This will be followed by Phase 1b dose confirmation and Phase 2 dose expansion parts to gain further efficacy and safety experience with 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
Estimated Enrollment : 270 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 in Subjects With Multiple Myeloma (ParadigMM-1B)
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : February 4, 2022
Estimated Study Completion Date : August 5, 2026

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: 60 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 = 3 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 combination in the same line or separate lines 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:

  • Known extramedullary relapse 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
  • Known history of primary plasma cell leukemia or evidence of primary or secondary plasma cell leukemia at the time of screening
  • Waldenstrom's macroglobulinemia
  • Prior amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met)
  • 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 any drug or construct that targets BCMA on tumor cells (eg, other bispecific antibody constructs, antibody drug conjugates, or CAR-T cells), other than Group C where prior treatment with GSK2857916 (belantamab mafodotin) is required.

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 identifier (NCT number): NCT03287908

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Contact: Amgen Call Center 866-572-6436

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United States, Arizona
Research Site Recruiting
Phoenix, Arizona, United States, 85054
United States, Arkansas
Research Site Recruiting
Little Rock, Arkansas, United States, 72205
United States, Florida
Research Site Recruiting
Jacksonville, Florida, United States, 32224
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60637
United States, Minnesota
Research Site Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Research Site Recruiting
New York, New York, United States, 10029
Research Site Recruiting
New York, New York, United States, 10032
Research Site Recruiting
New York, New York, United States, 10065
United States, North Carolina
Research Site Recruiting
Charlotte, North Carolina, United States, 28204
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Research Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, Victoria
Research Site Recruiting
Melbourne, Victoria, Australia, 3000
Research Site Recruiting
Melbourne, Victoria, Australia, 3004
Research Site Recruiting
Heidelberg, Germany, 69120
Research Site Recruiting
Kiel, Germany, 24105
Research Site Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Research Site Recruiting
Groningen, Netherlands, 9713 GZ
Research Site Recruiting
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen Identifier: NCT03287908    
Other Study ID Numbers: 20170122
2017-001997-41 ( EudraCT Number )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: February 2020
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.

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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:
Phase 1
Phase 2
Phase 1/2
Clinical Trial
Relapsed/Refractory Multiple Myeloma
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Multiple Myeloma
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases