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New combo aims to wipe out hidden myeloma cells after transplant

NCT ID NCT03901963

Disease control Sponsor: Janssen Research & Development, LLC 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial is testing whether adding daratumumab (a targeted antibody) to standard lenalidomide maintenance therapy can clear remaining cancer cells in people with multiple myeloma who still have minimal residual disease after a stem cell transplant. About 200 participants will receive either the combination or lenalidomide alone for up to 36 cycles. The main goal is to see if the combination leads to more patients becoming free of detectable cancer cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
daratumumab and lenalidomide
What this could lead to
If successful, this combination could help more patients achieve a state where no cancer cells are detectable, potentially delaying relapse and extending remission.
What could go wrong
This is an early-phase study with only 200 participants, and the long-term benefits are not yet proven. Adding daratumumab may increase side effects like infections or infusion reactions.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

200 people

The number who actually took part.

Started

Apr 2019

Finished

May 2026

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 to 79 years

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: * Must have newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT on the date of randomization * Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization * Must have archived bone marrow samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction) or have existing results on the index multiple myeloma clone based on Adaptive Biotechnologies' next generation sequencing (NGS)-based minimal residual disease (MRD) assay. Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by NGS. If an existing result on index myeloma clone is available from Adaptive Biotechnologies' NGS-based MRD assay, as part of institutional procedures, an archived bone marrow sample is not required as long as Adaptive Biotechnologies is able to retrieve historical results on the index myeloma clone form the clinical database. Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of -80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow aspirate clot sections (block or slides) for MRD assessment: (i) A formalin fixed paraffin embedded (FFPE) block of bone marrow aspirate clot, or slides (preferably 5, if available), 5 micrometer each, of non-decalcified bone marrow, or; (ii) Slides (preferably 5, if available), bone marrow aspirate smear; (iii) Please note, bone marrow core sections are not acceptable samples for analysis; (iv) In exceptional circumstances when index myeloma clone cannot be identified from the archived bone marrow sample, a post-transplant sample can be used to identify myeloma clone with permission from the sponsor * Must have residual disease as defined by detectable MRD (Adaptive Biotechnologies' NGS based MRD assay) * Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Exclusion Criteria: * A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease before the of date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years * Must not have progressed on multiple myeloma (MM) therapy at any time prior to screening * Have had prior treatment/therapy with: (a) Daratumumab or any other anti-cluster of differentiation 38 (CD38) therapies, (b) Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management, or (c) Plasmapheresis within 28 days of randomization * Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma * Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (\<) 50 percent (%) of predicted normal * Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification * Have any of the following: (a) Known history of seropositivity for human immunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; (c) Seropositive for hepatitis C (anti-hepatitis C virus \[HCV\] antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • Arizona Oncology Associates, PC - HAL

    Glendale, Arizona, 85308, United States

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU de Quebec Universite Laval Hopital de l Enfant Jesus

    Québec, Quebec, G1R 2J6, Canada

  • Cancer And Hematology Centers of Western Michigan PC

    Grand Rapids, Michigan, 49503, United States

  • Cancer Care Northwest

    Spokane, Washington, 99216, United States

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Cancer Treatment Center of America Phoenix

    Goodyear, Arizona, 85338, United States

  • Cancer Treatment Centers of America

    Zion, Illinois, 60099, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Fort Wayne Medical Oncology and Hematology American Oncology Partners

    Fort Wayne, Indiana, 46804, United States

  • Franciscan Health

    Indianapolis, Indiana, 46237-8601, United States

  • Greenville Health System Cancer Institute

    Greenville, South Carolina, 29615-4816, United States

  • HCA MidAmerica Division Inc Research Medical Center

    Kansas City, Missouri, 64132, United States

  • Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion

    Detroit, Michigan, 48202, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Illinois Cancer Specialists

    Niles, Illinois, 60714, United States

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mays Cancer Center (UT Health San Antonio)

    San Antonio, Texas, 78229, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Einstein Center for Cancer Care

    The Bronx, New York, 10467, United States

  • NYU Winthrop

    Mineola, New York, 11501, United States

  • New York Oncology Hematology

    Albany, New York, 12206, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Northwest Cancer Specialists PC

    Portland, Oregon, 97227, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Novant Health

    Winston-Salem, North Carolina, 27103, United States

  • Novant Health Charlotte

    Charlotte, North Carolina, 28204, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Oncology Hematology Care

    Cincinnati, Ohio, 45236, United States

  • Oregon Health And Science University

    Portland, Oregon, 97239, United States

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 1X6, Canada

  • Reading Hospital/McGlinn Cancer Institute

    West Reading, Pennsylvania, 19611, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)

    New Brunswick, New Jersey, 08901-1914, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Spartanburg Regional Health Services

    Spartanburg, South Carolina, 29303, United States

  • Summit Medical Group/MD Anderson Cancer Center

    Florham Park, New Jersey, 07932, United States

  • Temple University Hospital Jeanes Campus

    Philadelphia, Pennsylvania, 19111, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Texas Oncology P A

    Tyler, Texas, 75702, United States

  • Texas Oncology P A 1

    Dallas, Texas, 75246, United States

  • Texas Oncology-Central South

    Austin, Texas, 78745, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107-4215, United States

  • UCLA David Geffen School of Medicine

    Los Angeles, California, 90095, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • University Cancer And Blood Center LLC

    Athens, Georgia, 30607, United States

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Colorado Health

    Fort Collins, Colorado, 80528, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66160, United States

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7305, United States

  • University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic

    Charlottesville, Virginia, 22903, United States

  • University of Washington

    Seattle, Washington, 98109, United States

  • VA Puget Sound Healthcare System

    Seattle, Washington, 98108, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Yale University Medical Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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