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Relapsed/Refractory Multiple MyelomaPhase 1NCT03287908

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

A Phase 1 study testing AMG 701, Pomalidomide and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by Amgen at 34 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
AMG 701, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
34 sitesin 6 countries
Study dates
13 Nov 2017to 30 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

34 sites in 6 countries.

34 sites in 6 countries

United States17 sites

  • Winship Cancer Institute Emory U

    Atlanta, Georgia, 30322

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Chicago Medical Center - Multiple Myeloma Research Consortium

    Chicago, Illinois, 60637

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Icahn School of Medicine at Mount Sinai

    Hackensack, New Jersey, 07601

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • University of Arkansas for Medical Sciences Myeloma Institute Slot 816

    Little Rock, Arkansas, 72205

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Columbia University Medical Center

    New York, New York, 10032

  • New York Presbyterian Hospital, Weill Cornell Medical College

    New York, New York, 10065

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259

  • Washington University

    St Louis, Missouri, 63110

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan6 sites

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

Other trials in Japan

Australia3 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany3 sites

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Netherlands3 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Canada2 sites

  • McGill University Health Centre Glen Site

    Montreal, Quebec, H4A 3J1

  • University Health Network-Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1X6

Other trials in Canada

About this study

Official title: A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 Monotherapy, or in Combination With Pomalidomide, With and Without Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (ParadigMM-1B)

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.

Being tested
AMG 701, Pomalidomide, Dexamethasone
Keywords
Amgen, Phase 1, Phase 2, Phase 1/2, Clinical Trial, Oncology/Hematology, Relapsed/Refractory Multiple Myeloma, Immunotherapy
Medical subject headings
Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 701Drug

    Subjects will receive IV infusions of AMG 701.

  • PomalidomideDrug

    Subjects will receive oral capsules of pomalidomide.

  • DexamethasoneDrug

    Subjects will receive IV injections or oral dexamethasone.

Study groups in NCT03287908
Study groupRoleWhat they receive
AMG 701ExperimentalNot described
Receives: Drug: AMG 701
AMG 701 + PomalidomideExperimentalNot described
Receives: Drug: AMG 701; Drug: Pomalidomide
AMG 701 + Pomalidomide + DexamethasoneExperimentalNot described
Receives: Drug: AMG 701; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with dose-limiting toxicities (DLTs)

    Measured: 28 days

  2. Number of subjects with treatment emergent adverse events (TEAEs)

    Measured: 60 months

  3. Number of subjects with treatment-related adverse events

    Measured: 60 months

  4. Number of subjects with disease-related adverse events

    Measured: 60 months

  5. Number of subjects with clinically-significant changes in vital signs

    Measured: 48 months

  6. Number of subjects with clinically-significant changes in physical examination measurements

    Measured: 48 months

  7. Number of subjects with clinically-significant changes in electrocardiogram (ECG) measurements

    Measured: 48 months

  8. Number of subjects with clinically-significant changes in clinical laboratory tests

    Measured: 48 months

Secondary outcomes (15)

  1. Pharmacokinetic parameter of AMG 701: Maximum concentration (Cmax)

    Measured: 12 weeks

  2. Pharmacokinetic parameter of AMG 701: Time of maximum concentration (Tmax)

    Measured: 12 weeks

  3. Pharmacokinetic parameter of AMG 701: Area under the concentration-time curve (AUC)

    Measured: 12 weeks

  4. Pharmacokinetic parameter of AMG 701: Steady state concentration (Css)

    Measured: 12 weeks

  5. Anti-tumor activity: Overall response rate

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Best overall response of stringent CR (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

    Measured: 48 months

  6. Anti-tumor activity: Best overall response of stringent complete response (sCR)

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.

    Measured: 48 months

  7. Anti-tumor activity: Best overall response of complete response (CR)

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.

    Measured: 48 months

  8. Anti-tumor activity: Best overall response of very good partial response (VGPR)

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.

    Measured: 48 months

  9. Anti-tumor activity: Best overall response of partial response (PR)

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.

    Measured: 48 months

  10. Anti-tumor activity: Duration of response

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from the first PR or better to disease progression or death.

    Measured: 48 months

  11. Anti-tumor activity: Time to response

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.

    Measured: 48 months

  12. Anti-tumor activity: Progression-free survival

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from start of treatment until disease progression or death.

    Measured: 48 months

  13. Anti-tumor activity: Overall survival

    Defined as time from start of treatment until death due to any cause.

    Measured: 60 months

  14. Anti-tumor activity: Number of subjects with minimum residual disease negative complete response

    Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.

    Measured: 48 months

  15. Pharmacokinetic parameter of AMG 701: Trough concentration (Ctrough)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2017
  2. Study start13 Nov 2017
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Why it stopped: business decision, not safety reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03287908
Sponsor's protocol ID
20170122
Other IDs
2017-001997-41, 2017
Status last verified
Oct 2025
First submitted
6 Sep 2017
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Lee HC, Plattel WJ, Harrison SJ, Sborov DW, Lentzsch S, Spencer A, Niesvizky R, Trudel S, Mollee P, Vij R, Minnema MC, Rasche L, Upreti VV, Zhou D, Xia Q, Talpes M, Eggert T, Kapoor P, Ailawadhi S. A phase 1/1b study of the BCMA-targeting bispecific T-cell engager pavurutamab for relapsed/refractory multiple myeloma. Blood. 2026 Jul 9;148(2):199-212. doi: 10.1182/blood.2025032044.

    PubMed 41950113

  • 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.

    PubMed 32898244

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 701, Pomalidomide and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by Amgen at 34 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Japan, Australia, Germany, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: business decision, not safety reasons.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with dose-limiting toxicities (DLTs) (time frame: 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03287908, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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