Phase
Condition
Red Blood Cell Disorders
Bone Neoplasm
Lymphoproliferative Disorders
Treatment
Lenalidomide
Daratumumab
Clinical Study ID
Ages 18-79 All Genders
Study Summary
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
Connect with a study center
Princess Margaret Hospital
Toronto, Ontario M5G 1X6
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
CHU de Quebec Universite Laval Hopital de l Enfant Jesus
Quebec, G1R 2J6
CanadaSite Not Available
CHU de Quebec-Universite Laval-Hopital de l'Enfant-Jesus
Quebec, G1R 2J6
CanadaSite Not Available
CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus
Quebec, G1R 2J6
CanadaSite Not Available
University of Alabama Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Arizona Oncology Associates, PC - HAL
Glendale, Arizona 85308
United StatesSite Not Available
Cancer Treatment Center of America Phoenix
Goodyear, Arizona 85338
United StatesSite Not Available
Cancer Treatment Center of America, Phoenix
Goodyear, Arizona 85338
United StatesSite Not Available
University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
UCLA David Geffen School of Medicine
Los Angeles, California 90095
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94143
United StatesSite Not Available
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesSite Not Available
Rocky Mountain Cancer Centers
Denver, Colorado 80218
United StatesSite Not Available
University of Colorado Health
Fort Collins, Colorado 80528
United StatesSite Not Available
Yale University Medical Center
New Haven, Connecticut 06510
United StatesSite Not Available
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
United StatesSite Not Available
Cancer Specialists of North Florida
Jacksonville, Florida 32256
United StatesSite Not Available
Miami Cancer Institute
Miami, Florida 33176
United StatesSite Not Available
University of Miami Sylvester Cancer Center
Miami, Florida 33136
United StatesSite Not Available
University of Miami/Sylvester Cancer Center
Miami, Florida 33136
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Cleveland Clinic Florida
Weston, Florida 33331
United StatesSite Not Available
University Cancer & Blood Center, LLC
Athens, Georgia 30607
United StatesSite Not Available
University Cancer And Blood Center LLC
Athens, Georgia 30607
United StatesSite Not Available
Northside Hospital - Northside Hospital Cancer Institute
Atlanta, Georgia 30342-1606
United StatesSite Not Available
Georgia Cancer Center
Augusta, Georgia 30912
United StatesSite Not Available
Illinois Cancer Specialists
Niles, Illinois 60714
United StatesSite Not Available
Cancer Treatment Centers of America
Zion, Illinois 60099
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana 46804
United StatesSite Not Available
Franciscan Health
Indianapolis, Indiana 46237-8601
United StatesSite Not Available
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kansas Cancer Center
Westwood, Kansas 66160
United StatesSite Not Available
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
United StatesSite Not Available
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland 21201
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Henry Ford Cancer Institute
Detroit, Michigan 48202-2608
United StatesSite Not Available
Cancer & Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan 49503
United StatesSite Not Available
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan 49503
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
HCA MidAmerica Division Inc Research Medical Center
Kansas City, Missouri 64132
United StatesSite Not Available
Sarah Cannon Cancer Institute
Kansas City, Missouri 64132
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Summit Medical Group/MD Anderson Cancer Center
Florham Park, New Jersey 07932
United StatesSite 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 StatesSite Not Available
New York Oncology Hematology
Albany, New York 12206
United StatesSite Not Available
Montefiore Einstein Center for Cancer Care
Bronx, New York 10467
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesSite Not Available
Northwell Health
Lake Success, New York 11042
United StatesSite Not Available
NYU Winthrop
Mineola, New York 11501
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599-7305
United StatesSite Not Available
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina 28204
United StatesSite Not Available
Novant Health
Charlotte, North Carolina 28204
United StatesSite Not Available
Novant Oncology Research Institute
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Wake Forest Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Oncology Hematology Care
Cincinnati, Ohio 45236
United StatesSite Not Available
Northwest Cancer Specialists PC
Portland, Oregon 97227
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health And Science University
Portland, Oregon 97239
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107-4215
United StatesSite Not Available
University Of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15323
United StatesSite Not Available
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15323
United StatesSite Not Available
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania 15323
United StatesSite Not Available
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Reading Hospital/McGlinn Cancer Institute
West Reading, Pennsylvania 19611
United StatesSite Not Available
Greenville Health System Cancer Institute
Greenville, South Carolina 29615-4816
United StatesSite Not Available
Spartanburg Regional Health Services
Spartanburg, South Carolina 29303
United StatesSite Not Available
Tennessee Oncology
Chattanooga, Tennessee 37404
United StatesSite Not Available
Baptist Cancer Center
Memphis, Tennessee 38120
United StatesSite Not Available
Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Oncology P A
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology P.A.
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology P A
Dallas, Texas 75246
United StatesSite Not Available
Texas Oncology P.A.
Dallas, Texas 75246
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75235
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Mays Cancer Center (UT Health San Antonio)
San Antonio, Texas 78229
United StatesSite Not Available
Texas Oncology P A
Tyler, Texas 75702
United StatesSite Not Available
Texas Oncology P.A.
Tyler, Texas 75702
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
Charlottesville, Virginia 22903
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists
Gainesville, Virginia 20155
United StatesSite Not Available
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesSite Not Available
University of Washington
Seattle, Washington 98109
United StatesSite Not Available
VA Puget Sound Healthcare System
Seattle, Washington 98108
United StatesSite Not Available
Cancer Care Northwest
Spokane, Washington 99216
United StatesSite Not Available
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