A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT03287908
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
174 participants
INTERVENTIONAL
2017-11-13
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AMG 701
AMG 701
Subjects will receive IV infusions of AMG 701.
AMG 701 + Pomalidomide
AMG 701
Subjects will receive IV infusions of AMG 701.
Pomalidomide
Subjects will receive oral capsules of pomalidomide.
AMG 701 + Pomalidomide + Dexamethasone
AMG 701
Subjects will receive IV infusions of AMG 701.
Pomalidomide
Subjects will receive oral capsules of pomalidomide.
Dexamethasone
Subjects will receive IV injections or oral dexamethasone.
Interventions
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AMG 701
Subjects will receive IV infusions of AMG 701.
Pomalidomide
Subjects will receive oral capsules of pomalidomide.
Dexamethasone
Subjects will receive IV injections or oral dexamethasone.
Eligibility Criteria
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Inclusion 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 all approved and available therapies deemed eligible by the investigator, inclusing at a minimum of 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
* Subjects must have received ≥ 2 lines of prior therapy that must include a proteasome inhibitor (PI), lenalidomide, and where approved and available a CD38-directed antibody. These therapies may be in the same line or separate lines of treatment.
* Subjects must have responded to at least 1 prior line with at least a PR.
* Subjects that have previously received pomalidomide must not have been removed from therapy due to toxicity attributable to pomalidomide and must be at least 6 months from their last dose of pomalidomide.
* Subjects must not have known intolerance to doses of dexamethasone up to 40 mg weekly (20 mg weekly if \> 75 years).
Exclusion Criteria
* Known central nervous system involvement by multiple myeloma
* Autologous stem cell transplantation less than 90 days prior to study day 1
* Recent history of primary plasma cell leukemia (within last 6 months prior to enrollment) or evidence of primary or secondary plasma cell leukemia at the time of screening
* Waldenstrom's macroglobulinemia
* Prior amyloidosis (subjects 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.
* History of serious hypersensitivity associated with thalidomide, pomalidomide, or lenalidomide (\> grade 3).
* Multiple myeloma with IgM subtype.
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
* Contraindication to pomalidomide or dexamethasone.
* Glucocorticoid therapy within 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or equivalent dose of other corticosteroids.
* Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids (unless the dose is ≤ 10 mg/day prednisone or equivalent), cyclosporine, and tacrolimus within 2 weeks before study day 1 or 4 weeks before study day 1 for Phase 1 dose-confirmation.
* Female subjects of childbearing potential with a positive pregnancy test assessed within 14 days prior to first dose of study drugs and/or a positive urine pregnancy test within 24 hours prior to first dose. In addition, females of childbearing potential unwilling to undergo pregnancy testing weekly during the first 4 weeks of pomalidomide use followed by pregnancy testing every 4 weeks in females with regular menses or every 2 weeks in females with irregular menstrual cycles.
* Male subjects with a female partner of childbearing potential and female subjects of childbearing potential who are unwilling to use 2 methods of contraception (1 of which must be highly effective during the study and for an additional 75 days (females) and 135 days (males) after receiving the last dose of AMG 701, or 28 days after the last dose pomalidomide (males and females) or dexamethasone (females), whichever occurs later.
* Females who are lactating/breastfeeding or who plan to breastfeed while on study through 75 days after receiving the last dose of AMG 701, or 28 days after the last dose pomalidomide or dexamethasone, whichever occurs later.
* Females planning to become pregnant while on study through 75 days after receiving the last dose of AMG 701 or 28 days after the last dose pomalidomide or dexamethasone, whichever occurs later.
* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a latex or synthetic condom (even if they have had a vasectomy with medical confirmation of surgical success) during treatment (including during dose interruptions) and for an additional 135 days after the last dose of AMG 701, or 28 days after the last dose pomalidomide, whichever occurs later.
* Males who are unwilling to abstain from sperm donation while on study through 135 days after receiving the last dose of AMG 701 or 28 days after the last dose pomalidomide, whichever occurs later.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Mayo Clinic - Arizona
Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences Myeloma Institute Slot 816
Little Rock, Arkansas, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Winship Cancer Institute Emory U
Atlanta, Georgia, United States
University of Chicago Medical Center - Multiple Myeloma Research Consortium
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
University Health Network-Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, Canada
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig Holstein Campus Kiel
Kiel, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Countries
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References
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Cho SF, Lin L, Xing L, Li Y, Wen K, Yu T, Hsieh PA, Munshi N, Wahl J, Matthes K, Friedrich M, Arvedson T, Anderson KC, Tai YT. The immunomodulatory drugs lenalidomide and pomalidomide enhance the potency of AMG 701 in multiple myeloma preclinical models. Blood Adv. 2020 Sep 8;4(17):4195-4207. doi: 10.1182/bloodadvances.2020002524.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2017-001997-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20170122
Identifier Type: -
Identifier Source: org_study_id
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