A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Last updated: March 28, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Red Blood Cell Disorders

Bone Neoplasm

Lymphoproliferative Disorders

Treatment

Lenalidomide

Daratumumab

Clinical Study ID

NCT03901963
CR108599
54767414MMY3021
  • Ages 18-79
  • All Genders

Study Summary

The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have newly diagnosed multiple myeloma with a history of a minimum of 4 cyclesof induction therapy, have received high-dose therapy (HDT) and autologous stem celltransplantation (ASCT) within 12 months of the start of induction therapy, and bewithin 6 months of ASCT on the date of randomization

  • Must have a very good partial response (VGPR) or better response assessed perInternational Myeloma Working Group (IMWG) 2016 criteria at the time ofrandomization

  • Must have archived bone marrow samples collected before induction treatment (thatis, at diagnosis) or before transplant (for example, at the end of induction) orhave existing results on the index multiple myeloma clone based on AdaptiveBiotechnologies' next generation sequencing (NGS)-based minimal residual disease (MRD) assay. Archived bone marrow samples will be used for calibration of myelomaclonal cells to facilitate assessment of primary end point by NGS. If an existingresult on index myeloma clone is available from Adaptive Biotechnologies' NGS-basedMRD assay, as part of institutional procedures, an archived bone marrow sample isnot required as long as Adaptive Biotechnologies is able to retrieve historicalresults on the index myeloma clone form the clinical database. Any one of thefollowing archived samples are required: (a) Greater than 1 milliliter (mL) viablefrozen bone marrow aspirated aliquot (preferred) collected in anethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of -80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow aspirate clotsections (block or slides) for MRD assessment: (i) A formalin fixed paraffinembedded (FFPE) block of bone marrow aspirate clot, or slides (preferably 5, ifavailable), 5 micrometer each, of non-decalcified bone marrow, or; (ii) Slides (preferably 5, if available), bone marrow aspirate smear; (iii) Please note, bonemarrow core sections are not acceptable samples for analysis; (iv) In exceptionalcircumstances when index myeloma clone cannot be identified from the archived bonemarrow sample, a post-transplant sample can be used to identify myeloma clone withpermission 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

Exclusion Criteria:

  • A history of malignancy (other than multiple myeloma) unless all treatment of thatmalignancy was completed at least 2 years before consent and the participant has noevidence of disease before the of date of randomization. Exceptions are squamous andbasal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, orother non-invasive lesion that in the opinion of the investigator, with concurrencewith the sponsor's medical monitor, is considered cured with minimal risk ofrecurrence within 3 years

  • Must not have progressed on multiple myeloma (MM) therapy at any time prior toscreening

  • Have had prior treatment/therapy with: (a) Daratumumab or any other anti-cluster ofdifferentiation 38 (CD38) therapies, (b) Focal radiation therapy within 14 daysprior to randomization with the exception of palliative radiotherapy for symptomaticmanagement but not on measurable extramedullary plasmacytoma. Radiotherapy within 14days prior to randomization on measurable extramedullary plasmacytoma is notpermitted 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 dueto multiple myeloma

  • Have known chronic obstructive pulmonary disease (COPD) with a forced expiratoryvolume in 1 second (FEV1) less than (<) 50 percent (%) of predicted normal

  • Have known moderate or severe persistent asthma within the past 2 years or currentuncontrolled asthma of any classification

  • Have any of the following: (a) Known history of seropositivity for humanimmunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by apositive test for hepatitis B surface antigen [HBsAg]. Participants with resolvedinfection (that is, participants who are HBsAg negative but positive for antibodiesto hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surfaceantigen [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 willbe excluded. EXCEPTION: Participants with serologic findings suggestive of HBVvaccination (anti-HBs positivity as the only serologic marker) AND a known historyof 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 orHCV-RNA quantitation positive), except in the setting of a sustained virologicresponse, defined as aviremia at least 12 weeks after completion of antiviraltherapy)

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Lenalidomide
Phase: 3
Study Start date:
April 26, 2019
Estimated Completion Date:
May 29, 2026

Connect with a study center

  • Princess Margaret Hospital

    Toronto, Ontario M5G 1X6
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • CHU de Quebec Universite Laval Hopital de l Enfant Jesus

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • CHU de Quebec-Universite Laval-Hopital de l'Enfant-Jesus

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • University of Alabama Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Arizona Oncology Associates, PC - HAL

    Glendale, Arizona 85308
    United States

    Site Not Available

  • Cancer Treatment Center of America Phoenix

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • Cancer Treatment Center of America, Phoenix

    Goodyear, Arizona 85338
    United States

    Site Not Available

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

    La Jolla, California 92093
    United States

    Site Not Available

  • UCLA David Geffen School of Medicine

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers

    Denver, Colorado 80218
    United States

    Site Not Available

  • University of Colorado Health

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Yale University Medical Center

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Miami Cancer Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • University of Miami Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami/Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • University Cancer & Blood Center, LLC

    Athens, Georgia 30607
    United States

    Site Not Available

  • University Cancer And Blood Center LLC

    Athens, Georgia 30607
    United States

    Site Not Available

  • Northside Hospital - Northside Hospital Cancer Institute

    Atlanta, Georgia 30342-1606
    United States

    Site Not Available

  • Georgia Cancer Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Niles, Illinois 60714
    United States

    Site Not Available

  • Cancer Treatment Centers of America

    Zion, Illinois 60099
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Franciscan Health

    Indianapolis, Indiana 46237-8601
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Cancer Center

    Westwood, Kansas 66160
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Maryland, Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Henry Ford Cancer Institute

    Detroit, Michigan 48202-2608
    United States

    Site Not Available

  • Cancer & Hematology Centers of Western Michigan, PC

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Cancer And Hematology Centers of Western Michigan PC

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • HCA MidAmerica Division Inc Research Medical Center

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Sarah Cannon Cancer Institute

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Summit Medical Group/MD Anderson Cancer Center

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • 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

    Site Not Available

  • New York Oncology Hematology

    Albany, New York 12206
    United States

    Site Not Available

  • Montefiore Einstein Center for Cancer Care

    Bronx, New York 10467
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • NYU Winthrop

    Mineola, New York 11501
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599-7305
    United States

    Site Not Available

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Novant Health

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Novant Oncology Research Institute

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Oncology Hematology Care

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Northwest Cancer Specialists PC

    Portland, Oregon 97227
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health And Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107-4215
    United States

    Site Not Available

  • University Of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania 15323
    United States

    Site Not Available

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15323
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15323
    United States

    Site Not Available

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Reading Hospital/McGlinn Cancer Institute

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Greenville Health System Cancer Institute

    Greenville, South Carolina 29615-4816
    United States

    Site Not Available

  • Spartanburg Regional Health Services

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Tennessee Oncology

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Baptist Cancer Center

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology P A

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Oncology P.A.

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Oncology P A

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Oncology P.A.

    Dallas, Texas 75246
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Mays Cancer Center (UT Health San Antonio)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Oncology P A

    Tyler, Texas 75702
    United States

    Site Not Available

  • Texas Oncology P.A.

    Tyler, Texas 75702
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Gainesville, Virginia 20155
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

  • VA Puget Sound Healthcare System

    Seattle, Washington 98108
    United States

    Site Not Available

  • Cancer Care Northwest

    Spokane, Washington 99216
    United States

    Site Not Available

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