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

Study Purpose

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).

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 - 79 Years
Gender All
More Inclusion & Exclusion Criteria

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)

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.

NCT03901963
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 3
Lead Sponsor

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

Janssen Research & Development, LLC
Principal Investigator

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

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

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

Multiple Myeloma
Arms & Interventions

Arms

Experimental: Daratumumab + Lenalidomide

Participants will receive 1800 milligram (mg) daratumumab by subcutaneous (SC) injection in combination with lenalidomide (orally) as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.

Active Comparator: Lenalidomide

Participants will receive lenalidomide (orally) alone as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.

Interventions

Drug: - Daratumumab

Daratumumab 1800 mg will be administered by SC injection weekly during Cycles 1 and 2, every 2 weeks during Cycles 3 through 6, and every 4 weeks from Cycle 7 onward until confirmed progressive disease (PD), unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles.

Drug: - Lenalidomide

Lenalidomide 10 mg will be administered orally from Day 1 to Day 28 (continuously) of each 28-day cycle until confirmed PD, unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles. After 3 cycles of maintenance therapy, if well tolerated, the lenalidomide dose may be increased to 15 mg daily, at the discretion of the investigator.

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.

University of Alabama Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama Birmingham

Birmingham, Alabama, 35294

Arizona Oncology Associates, PC - HAL, Glendale, Arizona

Status

Recruiting

Address

Arizona Oncology Associates, PC - HAL

Glendale, Arizona, 85308

Goodyear, Arizona

Status

Recruiting

Address

Cancer Treatment Center of America, Phoenix

Goodyear, Arizona, 85338

La Jolla, California

Status

Recruiting

Address

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

La Jolla, California, 92093

UCLA David Geffen School of Medicine, Los Angeles, California

Status

Recruiting

Address

UCLA David Geffen School of Medicine

Los Angeles, California, 90095

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94143

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Rocky Mountain Cancer Centers, Denver, Colorado

Status

Recruiting

Address

Rocky Mountain Cancer Centers

Denver, Colorado, 80218

University of Colorado Health, Fort Collins, Colorado

Status

Recruiting

Address

University of Colorado Health

Fort Collins, Colorado, 80528

Yale University Medical Center, New Haven, Connecticut

Status

Recruiting

Address

Yale University Medical Center

New Haven, Connecticut, 06510

MedStar Georgetown University Hospital, Washington, District of Columbia

Status

Recruiting

Address

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

Cancer Specialists of North Florida, Jacksonville, Florida

Status

Recruiting

Address

Cancer Specialists of North Florida

Jacksonville, Florida, 32256

Miami, Florida

Status

Withdrawn

Address

University of Miami Leonard M. Miller School of Medicine - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136-1002

Miami, Florida

Status

Recruiting

Address

University of Miami/Sylvester Cancer Center

Miami, Florida, 33136

Miami Cancer Institute, Miami, Florida

Status

Recruiting

Address

Miami Cancer Institute

Miami, Florida, 33176

Moffitt Cancer Center, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Cleveland Clinic Florida, Weston, Florida

Status

Recruiting

Address

Cleveland Clinic Florida

Weston, Florida, 33331

University Cancer & Blood Center, LLC, Athens, Georgia

Status

Recruiting

Address

University Cancer & Blood Center, LLC

Athens, Georgia, 30607

Atlanta, Georgia

Status

Withdrawn

Address

Northside Hospital - Northside Hospital Cancer Institute

Atlanta, Georgia, 30342-1606

Georgia Cancer Center, Augusta, Georgia

Status

Withdrawn

Address

Georgia Cancer Center

Augusta, Georgia, 30912

Illinois Cancer Specialists, Niles, Illinois

Status

Recruiting

Address

Illinois Cancer Specialists

Niles, Illinois, 60714

Cancer Treatment Centers of America, Zion, Illinois

Status

Recruiting

Address

Cancer Treatment Centers of America

Zion, Illinois, 60099

Fort Wayne, Indiana

Status

Recruiting

Address

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46804

Franciscan Health, Indianapolis, Indiana

Status

Recruiting

Address

Franciscan Health

Indianapolis, Indiana, 46237-8601

University of Iowa Hospitals & Clinics, Iowa City, Iowa

Status

Withdrawn

Address

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242

University of Kansas Cancer Center, Westwood, Kansas

Status

Completed

Address

University of Kansas Cancer Center

Westwood, Kansas, 66160

Norton Cancer Institute, Louisville, Kentucky

Status

Completed

Address

Norton Cancer Institute

Louisville, Kentucky, 40207

Ochsner Clinic Foundation, New Orleans, Louisiana

Status

Recruiting

Address

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

Baltimore, Maryland

Status

Recruiting

Address

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, 21201

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Withdrawn

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Henry Ford Cancer Institute, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Cancer Institute

Detroit, Michigan, 48202-2608

Grand Rapids, Michigan

Status

Recruiting

Address

Cancer & Hematology Centers of Western Michigan, PC

Grand Rapids, Michigan, 49503

Mayo Clinic, Rochester, Minnesota

Status

Withdrawn

Address

Mayo Clinic

Rochester, Minnesota, 55905

University of Mississippi Medical Center, Jackson, Mississippi

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Sarah Cannon Cancer Institute, Kansas City, Missouri

Status

Recruiting

Address

Sarah Cannon Cancer Institute

Kansas City, Missouri, 64132

Washington University, Saint Louis, Missouri

Status

Withdrawn

Address

Washington University

Saint Louis, Missouri, 63110

Florham Park, New Jersey

Status

Completed

Address

Summit Medical Group/MD Anderson Cancer Center

Florham Park, New Jersey, 07932

New Brunswick, New Jersey

Status

Recruiting

Address

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

New Brunswick, New Jersey, 08901-1914

New York Oncology Hematology, Albany, New York

Status

Completed

Address

New York Oncology Hematology

Albany, New York, 12206

Bronx, New York

Status

Recruiting

Address

Montefiore Einstein Center for Cancer Care

Bronx, New York, 10467

Northwell Health, Lake Success, New York

Status

Recruiting

Address

Northwell Health

Lake Success, New York, 11042

NYU Winthrop, Mineola, New York

Status

Recruiting

Address

NYU Winthrop

Mineola, New York, 11501

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

University of Rochester Medical Center, Rochester, New York

Status

Withdrawn

Address

University of Rochester Medical Center

Rochester, New York, 14642

SUNY Upstate Medical University, Syracuse, New York

Status

Recruiting

Address

SUNY Upstate Medical University

Syracuse, New York, 13210

University of North Carolina, Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27599-7305

Charlotte, North Carolina

Status

Recruiting

Address

Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, 28204

Novant Health, Charlotte, North Carolina

Status

Recruiting

Address

Novant Health

Charlotte, North Carolina, 28204

Novant Oncology Research Institute, Winston-Salem, North Carolina

Status

Recruiting

Address

Novant Oncology Research Institute

Winston-Salem, North Carolina, 27103

Wake Forest Health Sciences, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157

Oncology Hematology Care, Cincinnati, Ohio

Status

Recruiting

Address

Oncology Hematology Care

Cincinnati, Ohio, 45236

Northwest Cancer Specialists PC, Portland, Oregon

Status

Completed

Address

Northwest Cancer Specialists PC

Portland, Oregon, 97227

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-4215

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

West Penn Hospital, Pittsburgh, Pennsylvania

Status

Recruiting

Address

West Penn Hospital

Pittsburgh, Pennsylvania, 15224

Pittsburgh, Pennsylvania

Status

Recruiting

Address

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

Pittsburgh, Pennsylvania, 15323

West Reading, Pennsylvania

Status

Recruiting

Address

Reading Hospital/McGlinn Cancer Institute

West Reading, Pennsylvania, 19611

Greenville, South Carolina

Status

Recruiting

Address

Greenville Health System Cancer Institute

Greenville, South Carolina, 29615-4816

Spartanburg Regional Health Services, Spartanburg, South Carolina

Status

Recruiting

Address

Spartanburg Regional Health Services

Spartanburg, South Carolina, 29303

Tennessee Oncology, Chattanooga, Tennessee

Status

Completed

Address

Tennessee Oncology

Chattanooga, Tennessee, 37404

Baptist Cancer Center, Memphis, Tennessee

Status

Recruiting

Address

Baptist Cancer Center

Memphis, Tennessee, 38120

Tennessee Oncology, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Oncology

Nashville, Tennessee, 37203

Vanderbilt University, Nashville, Tennessee

Status

Withdrawn

Address

Vanderbilt University

Nashville, Tennessee, 37203

Texas Oncology P.A., Austin, Texas

Status

Recruiting

Address

Texas Oncology P.A.

Austin, Texas, 78705

Texas Oncology P.A., Dallas, Texas

Status

Recruiting

Address

Texas Oncology P.A.

Dallas, Texas, 75246

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390-8565

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

San Antonio, Texas

Status

Recruiting

Address

Mays Cancer Center (UT Health San Antonio)

San Antonio, Texas, 78229

Texas Oncology P.A., Tyler, Texas

Status

Recruiting

Address

Texas Oncology P.A.

Tyler, Texas, 75702

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Charlottesville, Virginia

Status

Recruiting

Address

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

Charlottesville, Virginia, 22903

Virginia Cancer Specialists, Gainesville, Virginia

Status

Recruiting

Address

Virginia Cancer Specialists

Gainesville, Virginia, 20155

Virginia Oncology Associates, Norfolk, Virginia

Status

Recruiting

Address

Virginia Oncology Associates

Norfolk, Virginia, 23502

VA Puget Sound Healthcare System, Seattle, Washington

Status

Recruiting

Address

VA Puget Sound Healthcare System

Seattle, Washington, 98108

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98109

Cancer Care Northwest, Spokane, Washington

Status

Completed

Address

Cancer Care Northwest

Spokane, Washington, 99216

International Sites

Princess Margaret Hospital, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Hospital

Toronto, Ontario, M5G 1X6

McGill University Health Centre, Montreal, Quebec, Canada

Status

Recruiting

Address

McGill University Health Centre

Montreal, Quebec, H4A 3J1

Quebec, Canada

Status

Recruiting

Address

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

Quebec, , G1R 2J6