Multiple Myeloma Clinical Trial

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

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).

View Eligibility Criteria

Eligibility 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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

214

Study ID:

NCT03901963

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 78 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35294, United States
Arizona Oncology Associates, PC - HAL
Glendale Arizona, 85308, United States
Cancer Treatment Center of America, Phoenix
Goodyear Arizona, 85338, United States
University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center
La Jolla California, 92093, United States
UCLA David Geffen School of Medicine
Los Angeles California, 90095, United States
University of California San Francisco
San Francisco California, 94143, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
University of Colorado Health
Fort Collins Colorado, 80528, United States
Yale University Medical Center
New Haven Connecticut, 06510, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States
University of Miami Leonard M. Miller School of Medicine - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
University of Miami/Sylvester Cancer Center
Miami Florida, 33136, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Cleveland Clinic Florida
Weston Florida, 33331, United States
University Cancer & Blood Center, LLC
Athens Georgia, 30607, United States
Northside Hospital - Northside Hospital Cancer Institute
Atlanta Georgia, 30342, United States
Georgia Cancer Center
Augusta Georgia, 30912, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Cancer Treatment Centers of America
Zion Illinois, 60099, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne Indiana, 46804, United States
Franciscan Health
Indianapolis Indiana, 46237, United States
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States
University of Kansas Cancer Center
Westwood Kansas, 66160, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
University of Maryland, Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Cancer Institute
Detroit Michigan, 48202, United States
Cancer & Hematology Centers of Western Michigan, PC
Grand Rapids Michigan, 49503, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Sarah Cannon Cancer Institute
Kansas City Missouri, 64132, United States
Washington University
Saint Louis Missouri, 63110, United States
Summit Medical Group/MD Anderson Cancer Center
Florham Park New Jersey, 07932, United States
Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
New Brunswick New Jersey, 08901, United States
New York Oncology Hematology
Albany New York, 12206, United States
Montefiore Einstein Center for Cancer Care
Bronx New York, 10467, United States
Northwell Health
Lake Success New York, 11042, United States
NYU Winthrop
Mineola New York, 11501, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte North Carolina, 28204, United States
Novant Health
Charlotte North Carolina, 28204, United States
Novant Oncology Research Institute
Winston-Salem North Carolina, 27103, United States
Wake Forest Health Sciences
Winston-Salem North Carolina, 27157, United States
Oncology Hematology Care
Cincinnati Ohio, 45236, United States
Northwest Cancer Specialists PC
Portland Oregon, 97227, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh Pennsylvania, 15323, United States
Reading Hospital/McGlinn Cancer Institute
West Reading Pennsylvania, 19611, United States
Greenville Health System Cancer Institute
Greenville South Carolina, 29615, United States
Spartanburg Regional Health Services
Spartanburg South Carolina, 29303, United States
Tennessee Oncology
Chattanooga Tennessee, 37404, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Vanderbilt University
Nashville Tennessee, 37203, United States
Texas Oncology P.A.
Austin Texas, 78705, United States
Texas Oncology P.A.
Dallas Texas, 75246, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Mays Cancer Center (UT Health San Antonio)
San Antonio Texas, 78229, United States
Texas Oncology P.A.
Tyler Texas, 75702, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
Charlottesville Virginia, 22903, United States
Virginia Cancer Specialists
Gainesville Virginia, 20155, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
VA Puget Sound Healthcare System
Seattle Washington, 98108, United States
University of Washington
Seattle Washington, 98109, United States
Cancer Care Northwest
Spokane Washington, 99216, United States
Princess Margaret Hospital
Toronto Ontario, M5G 1, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus
Quebec , G1R 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

214

Study ID:

NCT03901963

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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