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Experimental myeloma drug AMG 701 trial halted early

NCT ID NCT03287908

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called AMG 701, alone or with other medicines, in 174 adults with multiple myeloma that returned or didn't respond to prior treatments. The main goals were to check safety and find the best dose. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

174 people

The number who actually took part.

Started

Nov 2017

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Inclusion criteria specific to AMG 701-P±d include: * 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 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 * 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. Exclusion criteria specific to AMG 701-P±d include: * 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.

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Conditions

The condition(s) this trial relates to.

neoplasm plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory multiple myeloma

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511, Japan

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Icahn School of Medicine at Mount Sinai

    Hackensack, New Jersey, 07601, United States

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX, Netherlands

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • McGill University Health Centre Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192, Japan

  • New York Presbyterian Hospital, Weill Cornell Medical College

    New York, New York, 10065, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • University Health Network-Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1X6, Canada

  • University of Arkansas for Medical Sciences Myeloma Institute Slot 816

    Little Rock, Arkansas, 72205, United States

  • University of Chicago Medical Center - Multiple Myeloma Research Consortium

    Chicago, Illinois, 60637, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105, Germany

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute Emory U

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.