Multiple Myeloma Clinical Trial

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

Summary

The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

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Full Description

The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria

Measurable, secretory disease as defined by any of the following:

Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or
Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or
Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio

Meets one of the sets of the following criteria:

For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
During the study, during dose interruptions, and for 3 months after receiving the last dose of any component of the study treatment, a female participant must agree not to donate eggs (ova, oocytes) and male participants of reproductive potential must not donate semen or sperm during the study, during dose interruptions, or for 3 months after the last dose of any study drug

Exclusion Criteria:

History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and 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
Exhibits clinical signs of meningeal involvement of MM
Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension
Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (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 polymerase chain reaction (PCR) positive will be excluded
Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy
For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

265

Study ID:

NCT03412565

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 64 Locations for this study

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Cancer Center of Central Connecticut - Southington
Southington Connecticut, 06489, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
UF Health Cancer Center at Orlando Health
Orlando Florida, 32806, United States
Karmonos Cancer Institute
Detroit Michigan, 48201, United States
Providence Cancer Center
Southfield Michigan, 48075, United States
Billings Clinic
Billings Montana, 59101, United States
Nebraska Hematology and Oncology
Lincoln Nebraska, 68506, United States
Southeast Nebraska Cancer Center
Lincoln Nebraska, 68510, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
NYU Winthrop
Mineola New York, 11501, United States
Mt. Sinai School of Medicine
New York New York, 10029, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Avera Medical Group - Oncology & Hematology
Sioux Falls South Dakota, 57105, United States
Utah Cancer Specialists
Salt Lake City Utah, 84121, United States
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
Charlottesville Virginia, 22903, United States
Liga Norte Riograndense Contra O Cancer
Natal , 59062, Brazil
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
Passo Fundo , 99010, Brazil
Ministerio da Saude - Instituto Nacional do Cancer
Rio de Janeiro , 20230, Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
Sao Paulo , 04037, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
Sao Paulo , 04039, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 70852, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Praha 2 , 128 0, Czechia
CHU de Nantes hôtel-Dieu
Nantes Cedex 1 , 44093, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac cedex , 33604, France
Centre hospitalier Lyon-Sud
Pierre-Bénite , 69495, France
CHU Bretonneau
Tours Cedex 9 , 37044, France
CHU Nancy Brabois
Vandoeuvre Les Nancy , 54511, France
Klinikum Chemnitz gGmbH
Chemnitz , 09113, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg , 20246, Germany
Asklepios Klinik Altona
Hamburg , 22763, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen , 72076, Germany
Rambam Medical Center
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Galilee Medical Center
Nahariya , 22100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv , 64239, Israel
Kanazawa University Hospital
Kanazawa , 920-8, Japan
Matsuyama Red Cross Hospital
Matsuyama , 790-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
Inst. Cat. D'Oncologia-Badalona
Badalona , 08916, Spain
Hosp. Clinic I Provincial De Barcelona
Barcelona , 08036, Spain
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona , 08908, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 8035, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Clinica Univ. de Navarra
Madrid , 28027, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Son Llatzer
Mallorca , 07198, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Dr. Peset
Valencia , 46017, Spain
Heart of England NHS Foundation Trust
Birmingham , B9 5S, United Kingdom
Royal Bournemouth Hospital
Bournemouth , BH7 7, United Kingdom
Kent and Canterbury Hospital
Canterbury , CT1 3, United Kingdom
Manchester Royal Infirmary
Manchester , M13 9, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Royal Stoke University Hospital
Stoke on Trent , ST4 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

265

Study ID:

NCT03412565

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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