Multiple Myeloma Clinical Trial

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Summary

The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.

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Full Description

This study will evaluate participants with newly diagnosed multiple myeloma (MM) for whom hematopoietic stem cell transplant is not planned as initial therapy. The data available from other available studies suggests that addition of daratumumab with Velcade (bortezomib), lenalidomide, and dexamethasone [VRd] is anticipated to improve the response rates and the depth of response and may lead to improved long-term outcomes in newly diagnosed participants with MM. Daratumumab targets CD38, a protein expressed on the surface of MM cells and other hematopoietic cells. Bortezomib is a proteasome inhibitor, which plays a critical role in the pathogenesis of MM. Lenalidomide has cytotoxic effects on myeloma cells and is capable of inducing apoptosis, or programmed cell death and dexamethasone induces apoptosis in MM cells. The rationale for the study is to utilize the subcutaneous (SC) formulation of daratumumab instead of the intravenous (IV) formulation, which is expected to provide similar exposure and is expected to limit additional toxicity to participants, treated with this quadruplet regimen. The study will consist of 3 phases: Screening (up to 28 days before randomization), Treatment phase (from Cycle 1 [21 days] Day 1 and continues until disease progression) and Follow up (Postintervention). Efficacy evaluations will include measurements of tumor burden/residual disease, myeloma proteins, bone marrow examinations, skeletal surveys, extramedullary plasmacytomas, and serum calcium corrected for albumin. Participants will undergo procedures like electrocardiogram (ECG), chest x-rays or full dose chest CT scans, Pulmonary function test (PFT), spirometry etc. during the course of study. Participants will also be monitored closely for adverse events (AEs), laboratory abnormalities, and clinical response. The duration of the study will be approximately 6.5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

- Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25 millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine clearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.

Biomarkers of Malignancy: Clonal bone marrow plasma cell percentage >=60%; Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion on magnetic resonance imaging (MRI) studies

Must have measurable disease, as assessed by central laboratory
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen

Exclusion Criteria:

Frailty index of >=2 according to Myeloma Geriatric Assessment score
Prior therapy for multiple myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day, total of 160 mg dexamethasone or equivalent)
Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma 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)
Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
Focal radiation therapy within 14 days of randomization with the exception of palliative radiotherapy for symptomatic pain management. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

395

Study ID:

NCT03652064

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 114 Locations for this study

See Locations Near You

Innovative Clinical Research Inc
Cerritos California, 90703, United States
Baptist MD Anderson
Jacksonville Florida, 32207, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne Indiana, 46804, United States
Norton Healthcare
Louisville Kentucky, 40207, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids Michigan, 49503, United States
Saint Luke's Hospital - Saint Luke's Cancer Specialists
Kansas City Missouri, 64111, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Winthrop
Mineola New York, 11501, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Good Samaritan Hospital Corvallis
Corvallis Oregon, 97330, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Gibbs Cancer Center
Spartanburg South Carolina, 29303, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Virginia
Charlottesville Virginia, 22908, United States
Universidade Estadual De Campinas
Campinas , 13083, Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59062, Brazil
Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS
Porto Alegre , 90610, Brazil
Ministerio da Saude - Instituto Nacional do Cancer
Rio de Janeiro , 20230, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22775, Brazil
Instituto de Ensino e Pesquisa São Lucas
Sao Paulo , 01236, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
Sao Paulo , 01323, Brazil
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
Sao Paulo , 03102, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Hospital Santa Cruz
São Paulo , 04122, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
The Gordon & Leslie Diamond Health Care Center
Vancouver British Columbia, V5Z 1, Canada
QEII Health Sciences Centre
Halifax Nova Scotia, B3H 1, Canada
Brampton Civic Hospital
Brampton Ontario, L6R 3, Canada
Victoria Hospital
London Ontario, N6A 5, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G-2, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
CHU de Quebec L Hotel Dieu de Quebec
Quebec , G1J 1, Canada
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 708 5, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Plzen , 323 0, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
CHU Henri Mondor
Creteil N/a , 94010, France
Centre Hospitalier Départmental La Roche sur Yon
La Roche sur Yon Cedex 9 , 85925, France
Hopital Claude Huriez
Lille , 59037, France
Institut Paoli Calmettes
Marseille Cedex 9 , 13009, France
CHU de Montpellier, Hopital Saint-Eloi
Montpellier , 34295, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac cedex , 33604, France
Strasbourg Oncologie Libérale
Strasbourg , 67000, France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse cedex 9 , 31059, France
phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg
Aschaffenburg , 63739, Germany
Universitatsklinikum Freiburg
Freiburg , 79106, Germany
St. Josef-Krankenhaus Hamm-Bockum-Hövel
Hamm , 59075, Germany
Institut für Versorgungsforschung
Koblenz , 56068, Germany
Universitatsmedizin Leipzig
Leipzig , 4103, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität
München , 81377, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tuebingen , 72076, Germany
Barzilai Medical Center
Ashkelon , 78741, Israel
Hillel Yaffe Medical Center
Hadera , 38100, Israel
Rambam Med.Center - Hematology Institute
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Meir Hospital
Kfar Saba , 44281, Israel
Rabin Medical Center
Petah-Tiqva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Sourasky (Ichilov) Medical Center
Tel Aviv , 64239, Israel
Fukuoka University Hospital
Fukuoka , 814-0, Japan
Ogaki Municipal Hospital
Gifu , 503-8, Japan
Kobe City Medical Center General Hospital
Hyogo , 650-0, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto-shi , 860-0, Japan
University Hospital Kyoto Perfectural University of Medicine
Kyoto , 602-8, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto , 399-8, Japan
Matsuyama Red Cross Hospital
Matsuyama , 790-8, Japan
Nagoya City University Hospital
Nagoya , 467 8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Japanese Red Cross Osaka Hospital
Osaka , 543-8, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa , 377-0, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht , 3318 , Netherlands
Erasmus MC
Rotterdam , 3015C, Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozow , 36-20, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów , 41-50, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce , 25-73, Poland
NSSU Szpital Uniwersytecki w Krakowie
Krakow , 30 68, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin , 20090, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan , 60-56, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Slupsk , 76-20, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Hosp. Univ. Fundacion Alcorcon
Alcorcon , 28922, Spain
Hosp. Del Mar
Barcelona , 08003, Spain
Hosp. Univ. de Guadalajara
Guadalajara , 19002, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda , 28222, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo De Alarcon, Madrid , 28223, Spain
Hosp. Mutua Terrassa
Terrassa , 08221, Spain
Gulhane Egitim ve Arastirma Hastanesi
Ankara , 06010, Turkey
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara , 06200, Turkey
Ankara University School of Medicine, Cebeci Hospital
Ankara , 06590, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34093, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35340, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun , 55280, Turkey
Monklands District General Hospital
Airdrie , ML6 0, United Kingdom
Blackpool Victoria Hospital
Blackpool , FY3 8, United Kingdom
University Hospital Wales
Cardiff , CF14 , United Kingdom
Colchester Hospital University NHS
Colchester , CO4 5, United Kingdom
Leicester Royal Infirmary - Haematology
Leicester , LE1 5, United Kingdom
Altnagelvin Hospital
Londonderry , BT47 , United Kingdom
The Royal Oldham Hospital
Oldham , OL1 2, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

395

Study ID:

NCT03652064

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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