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New combo for tough myeloma cases shows early promise, but study halted

NCT ID NCT03837509

Disease control Sponsor: Incyte Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding an experimental drug (INCB001158) to a standard therapy (daratumumab) could help people with multiple myeloma that returned or didn't respond to prior treatments. The trial enrolled 15 adults who had already tried at least 3 other therapies. The goal was to check safety and see if the combination worked better than daratumumab alone. The study was terminated 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

15 people

The number who actually took part.

Started

Sep 2019

Finished

Apr 2022

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: * Prior diagnosis of multiple myeloma according to IMWG diagnostic criteria. * Measurable disease at screening. * Has received at least 3 but not more than 5 prior lines of multiple myeloma treatment, including proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapies. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Willing to avoid pregnancy or fathering children. * Willing to provide fresh and archival bone marrow aspiration and biopsy tissue. Exclusion Criteria: * Receipt of any of the following treatment within the indicated interval before the first administration of study drug: * Anti-myeloma treatment within 2 weeks or 5 half-lives (whichever is longer). * Investigational drug (including investigational vaccines) or invasive investigational medical device within 4 weeks. * Autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant at any time. * Plasmapheresis within 4 weeks. * Radiation therapy within 2 weeks. * Major surgery within 2 weeks, or inadequate recovery from an earlier surgery, or surgery planned during the time the participant is expected to participate in the study or within 2 weeks after the last dose of study treatment. * Toxicity ≥ Grade 2 from previous anti-myeloma therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy. * Known additional malignancy (other than multiple myeloma) that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. * Laboratory values at screening outside the protocol-defined range. * Significant concurrent, uncontrolled medical condition including but not limited to known chronic obstructive pulmonary disease (COPD), persistent asthma, or history of asthma within the past 2 years; chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment; acute diffuse infiltrative pulmonary disease; clinically significant or uncontrolled cardiac disease. * Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloidosis.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence refractory plasma cell neoplasm

As listed by the trial registrant

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

Relapsed or refractory multiple myeloma

Contacts and locations

Locations

  • Arizona Oncology Associates (Wilmot)

    Tucson, Arizona, 85711, United States

  • Charite - Universit�Tsmedizin Berlin

    Berlin, 13353, Germany

  • Clinica Universidad de Navarra (Cun)

    Pamplona, 31008, Spain

  • Comprehensive Cancer Centers of Nevada - Twain

    Las Vegas, Nevada, 89169, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040, Spain

  • Hospital Clinic I Provincial

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital General Universitari Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Y Politcnico de La Fe

    Valencia, 46026, Spain

  • Ico Institut Catala D Oncologia

    Barcelona, 08908, Spain

  • Lineberger Comprehensive Cancer Center At University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • New York Oncology Hematology

    Albany, New York, 12206, United States

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45236, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Southern Cancer Center

    Daphne, Alabama, 36526, United States

  • Texas Oncology - Fort Worth South Henderson

    Fort Worth, Texas, 76104, United States

  • Texas Oncology - Tyler

    Tyler, Texas, 75702, United States

  • Texas Oncology San Antonio

    San Antonio, Texas, 78240, United States

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705, United States

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131, Germany

  • University of Heidelberg

    Heidelberg, 69117, Germany

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Virginia Cancer Specialists-Fairfax

    Fairfax, Virginia, 22031, United States

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