A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Study Purpose

The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will include a sequential dose exploration part to identify the RP2D of AMG 701 in combination with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of the dose-expansion part to gain further efficacy and safety experience with AMG 701 monotherapy in adult subjects with RRMM.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 = 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03287908
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Germany, Japan, Netherlands, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/Refractory Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: AMG 701

Experimental: AMG 701 + Pomalidomide

Experimental: AMG 701 + Pomalidomide + Dexamethasone

Interventions

Drug: - AMG 701

Subjects will receive IV infusions of AMG 701.

Drug: - Pomalidomide

Subjects will receive oral capsules of pomalidomide.

Drug: - Dexamethasone

Subjects will receive IV injections or oral dexamethasone.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic - Arizona, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic - Arizona

Scottsdale, Arizona, 85259

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas for Medical Sciences Myeloma Institute Slot 816

Little Rock, Arkansas, 72205

Mayo Clinic Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Florida

Jacksonville, Florida, 32224

Winship Cancer Institute Emory U, Atlanta, Georgia

Status

Recruiting

Address

Winship Cancer Institute Emory U

Atlanta, Georgia, 30322

Chicago, Illinois

Status

Recruiting

Address

University of Chicago Medical Center - Multiple Myeloma Research Consortium

Chicago, Illinois, 60637

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63110

Hackensack University Medical Center, Hackensack, New Jersey

Status

Completed

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Icahn School of Medicine at Mount Sinai, Hackensack, New Jersey

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

Hackensack, New Jersey, 07601

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

New York, New York

Status

Recruiting

Address

New York Presbyterian Hospital, Weill Cornell Medical College

New York, New York, 10065

Levine Cancer Institute, Charlotte, North Carolina

Status

Terminated

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

Wake Forest Baptist Health, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112

The Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

Toronto, Ontario, Canada

Status

Recruiting

Address

University Health Network-Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6

Montreal, Quebec, Canada

Status

Terminated

Address

McGill University Health Centre Glen Site

Montreal, Quebec, H4A 3J1

Universitätsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitätsklinikum Heidelberg

Heidelberg, , 69120

Kiel, Germany

Status

Recruiting

Address

Universitätsklinikum Schleswig Holstein Campus Kiel

Kiel, , 24105

Universitaetsklinikum Wuerzburg, Wuerzburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Wuerzburg

Wuerzburg, , 97080

Nagoya City University Hospital, Nagoya-shi, Aichi, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya-shi, Aichi, 467-8602

Gunma University Hospital, Maebashi-shi, Gunma, Japan

Status

Recruiting

Address

Gunma University Hospital

Maebashi-shi, Gunma, 371-8511

Kobe-shi, Hyogo, Japan

Status

Recruiting

Address

Kobe City Medical Center General Hospital

Kobe-shi, Hyogo, 650-0047

Kanazawa University Hospital, Kanazawa-shi, Ishikawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital

Kanazawa-shi, Ishikawa, 920-8641

Okayama-shi, Okayama, Japan

Status

Recruiting

Address

National Hospital Organization Okayama Medical Center

Okayama-shi, Okayama, 701-1192

Koto-ku, Tokyo, Japan

Status

Completed

Address

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550

Universitair Medisch Centrum Groningen, Groningen, Netherlands

Status

Recruiting

Address

Universitair Medisch Centrum Groningen

Groningen, , 9713 GZ

Maastricht Universitair Medisch Centrum, Maastricht, Netherlands

Status

Completed

Address

Maastricht Universitair Medisch Centrum

Maastricht, , 6229 HX

Universitair Medisch Centrum Utrecht, Utrecht, Netherlands

Status

Recruiting

Address

Universitair Medisch Centrum Utrecht

Utrecht, , 3584 CX