Multiple Myeloma Clinical Trial

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Summary

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

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Full Description

This study consists of 3 phases: Screening Phase (up to 35 days), an Active Monitoring Phase or a Treatment Phase of 39 cycles or 36 months (whichever occurs first), and a Follow-up Phase which will continue until death, lost to follow-up, consent withdrawal, or study end (approximately 8 years after the first participant is randomized), whichever occurs first. Active monitoring cycles and treatment cycles are 4 weeks in length. For all participants, disease evaluations will be performed every 12 weeks until confirmed progressive disease (PD). After PD, survival is to be followed at least every 6 months, until the end of the study. Participants will undergo tumor assessments, pharmacokinetics, biomarkers and safety evaluations (adverse events, laboratory tests, vital sign measurements, physical examinations, Eastern Cooperative Oncology Group [ECOG] performance status) over the time.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma Working Group [IMWG] criteria) for less than or equal to (<=) 5 years with measurable disease at the time of randomization, defined as serum M protein greater than or equal to (>=) 10 gram per liter (g/L) or urine M protein >= 200 milligram per 24 hours (mg/24 hours) or involved serum free light chain (FLC) >=100 milligram per liter (mg/L) and abnormal serum FLC ratio
Clonal bone marrow plasma cells (BMPCs) >= 10 percentage (%); and at least 1 of the following risk factors; Serum M protein >= 30 g/L, immunoglobulin (Ig)A SMM, immunoparesis with reduction of 2 uninvolved immunoglobulin isotypes (only IgA, IgM, and IgG should be considered in determination for immunoparesis; IgD and IgE are not considered in this assessment), serum involved: uninvolved FLC ratio >= 8 and less than (<) 100, or clonal BMPCs greater than (>) 50% to <60% with measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use highly effective method of contraception
A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days prior to randomization
During the study and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction

Exclusion Criteria:

Multiple myeloma (MM), requiring treatment, defined by any of the following:

Bone lesions (1 or more osteolytic lesions on low-dose whole body computed tomography [LDCT], positron-emission tomography with computed tomography [PET-CT] or CT). Participants who have benign/post-traumatic bone lesions visible on screening images as well as previous imaging, may be considered for inclusion. Details (diagnosis, location, duration) on benign/post-traumatic pre-existing bone lesions that can be seen on the screening images (example [eg.], old fractures) and were also present on previous imaging are to be reported in the case report form (CRF)
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]). Participants who have clinically stable hypercalcemia attributable to a disease other than multiple myeloma (eg, hyperparathyroidism) may be considered for inclusion after a case by case review by the medical monitor
Renal insufficiency, preferably determined by creatinine clearance less than (<)40 milliliter per minute (mL/min) measured or estimated using the Modification of Diet in Renal Disease (MDRD), or serum creatinine >177 micromole per liter (μmol/L). Participants who have clinically stable renal insufficiency attributable to a disease other than multiple myeloma (eg, glomerulonephritis) may be considered for inclusion after a case by case review by the medical monitor
Anemia, defined as hemoglobin <10 gram per deciliter (gdL) or>2 g/dL below lower limit of normal or both; transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted. Participants who have clinically stable anemia attributable to a disease other than multiple myeloma (eg, thalassemia, vitamin B12 deficiency, iron deficiency) may be considered for inclusion after a case by case review by the medical monitor
Clonal BMPC percentage >=60%
Serum FLC ratio (involved:uninvolved) >=100 (the involved FLC must be >=100 mg/L)
More than 1 focal lesion >=5 millimeter (mm) in diameter by magnetic resonance imaging (MRI)
Primary systemic amyloid light-chain (AL) (immunoglobulin light chain) amyloidosis

Exposure to any of the following:

Prior exposure to daratumumab or prior exposure to other anti-Cluster of Differentiation 38 (anti-CD38) therapies
Prior exposure to approved or investigational treatments for SMM or MM (including but not limited to conventional chemotherapies, immunomodulatory agent [IMiDs], or proteasome inhibitor [PIs]). Stable standard dosing of bisphosphonate and denosumab as indicated for osteoporosis is acceptable
Exposure to investigational drug (including investigational vaccines) or invasive investigational medical device for any indication within 4 weeks or 5 half-lives, whichever is longer, before Cycle 1, Day 1
Ongoing treatment with corticosteroids with a dose >10 milligram (mg) prednisone or equivalent per day at the time of randomization; or >280 mg cumulative prednisone dose or equivalent for any 4-week period in the year prior to randomization
Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab), immunomodulators (eg, abatacept, methotrexate, azathioprine, cyclosporine) or other treatments that are likely to interfere with the study procedures or results
Received treatment (chemotherapy, surgery, et cetera [etc]) for a malignancy (other than SMM) within 3 years before the 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), which is considered cured with minimal risk of recurrence within 3 years
Medical or psychiatric condition or disease (for example, active systemic disease [including presence of auto-antibodies], uncontrolled diabetes) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies, hyaluronidase, or other human proteins, or their excipients, or known sensitivity to mammalian-derived products (including dairy allergy)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

390

Study ID:

NCT03301220

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 161 Locations for this study

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Arizona Oncology Associates, PC - HAL
Phoenix Arizona, 85016, United States
Innovative Clinical Research, Inc.
Whittier California, 90805, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Emory University
Atlanta Georgia, 30322, United States
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States
East Jefferson General Hospital
Metairie Louisiana, 70006, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University
Saint Louis Missouri, 63110, United States
VA Southern Nevada Healthcare
North Las Vegas Nevada, 89086, United States
New York Oncology Hematology
Albany New York, 12206, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, 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
Cleveland Clinic
Cleveland Ohio, 44195, United States
The Ohio State University
Columbus Ohio, 43210, United States
OHSU/CHM
Portland Oregon, 97239, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Texas Oncology P.A.
Austin Texas, 78705, United States
VA North Texas Health Care System
Dallas Texas, 75216, United States
Texas Oncology P.A.
Tyler Texas, 75702, United States
University of Washington
Seattle Washington, 90805, United States
Hospital Aleman
Buenos Aires , C1118, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires , C1199, Argentina
CEMIC Saavedra
Ciudad de Buenos Aires , 1431, Argentina
Hospital Privado - Centro Medico de Cordoba
Cordoba , X5016, Argentina
Hospital Italiano de La Plata
La Plata , B1900, Argentina
Sanatorio Britanico de Rosario
Rosario , 2000, Argentina
Austin Hospital
Heidelberg , 3150 , Australia
Calvary Mater Newcastle Hospital
Waratah , 2298, Australia
The Perth Blood Institute
West Perth , 6005, Australia
Queen Elizabeth Hospital
Woodville , 5011, Australia
ZNA
Antwerpen , 2060, Belgium
AZ St.-Jan Brugge-Oostende AV
Brugge , 8000, Belgium
UZBrussel
Brussel , 1090, Belgium
UZ Gent
Gent , 9000, Belgium
Virga Jessa Ziekenhuis
Hasselt , 3500, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Centro de Pesquisas Oncológicas - CEPON
Florianópolis , 88034, Brazil
Hospital Das Clinicas Da Universidade Federal De Goias
Goiânia , 74605, Brazil
Instituto Joinvilensse de Hematologia e Oncologia
Joinville , 89201, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre , 90035, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22793, Brazil
Hospital Sao Rafael
Salvador , 41235, Brazil
Instituto de Ensino e Pesquisa São Lucas
Sao Paulo , 01236, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
São José do Rio Preto , 15090, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Hospital Santa Cruz
São Paulo , 04122, Brazil
Tom Baker Cancer Center, University of Calgary
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G-2, Canada
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 70852, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Plzen , 323 0, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Praha 2 , 128 0, Czechia
Aarhus University Hospital
Aarhus N. , 8200, Denmark
Rigshospitalet
Copenhagen , 2100, Denmark
Odense Universitetshospital
Odense C , 5000, Denmark
Ålborg Universitetshospital
Ålborg , 9000, Denmark
CHU de Limoges - Fédération Hépatologie
Limoges , 87000, France
Chu Hotel Dieu
Nantes cedex 01 , 44035, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac cedex , 33604, France
Centre hospitalier Lyon-Sud
Pierre Benite cedex , 69495, France
CHU De Poitiers
Poitiers , 86021, France
l'Hôpital Pontchaillou
Rennes , 35033, France
CHU Bretonneau
Tours Cedex 9 , 37044, France
Helios Kliniken Berlin Buch Gmbh
Berlin , 13125, Germany
St. Barbara-Klinik Hamm GmbH
Hamm , 59075, Germany
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg , 69120, Germany
Medizinische Klinik A
Muenster , 48149, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen , 72076, Germany
Universitaetsklinikum Ulm
Ulm , 89081, Germany
Alexandra General Hospital of Athens
Athens Attica , 115 2, Greece
Semmelweis Egyetem, I. Belgyogyaszati Klinika
Budapest N/a , 1083, Hungary
Semmelweis Egyetem I.Belgyogyaszati Klinika
Budapest , 1088, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
Budapest , 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Haemek
Afula , 18101, Israel
Barzilai Medical Center
Ashkelon , 78741, Israel
Bnai Zion Medical Center
Haifa , 31048, Israel
Carmel Medical Center
Haifa , 34362, Israel
Rambam Medical Center
Haifa , 35254, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Galilee Medical Center
Nahariya , 22100, Israel
Rabin Medical Center
Petah-Tiqva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Sourasky Medical Center
Tel-Aviv , 64239, Israel
Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
Businco Cancer Hospital
Cagliari , 09121, Italy
A.O. Santa Croce e Carle
Cuneo , 12100, Italy
Ospedale S. Eugenio
Roma , 00144, Italy
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
Roma , 00161, Italy
A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia
Torino , 10126, Italy
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
Varese , 21100, Italy
Fukuoka University Hospital
Fukuoka , 814-0, Japan
Chugoku Central Hospital
Fukuyama , 720-0, Japan
Ogaki Municipal Hospital
Gifu , 503-8, Japan
Kobe City Medical Center General Hospital
Hyogo , 650-0, Japan
Kagoshima University Hospital
Kagoshima , 890-8, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano , 586-8, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto-shi , 860-0, Japan
Kurume University Hospital
Kurume , 830-0, Japan
Kyoto Kuramaguchi Medical Center
Kyoto , 603-8, 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
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
National Hospital Organization Sendai Medical Center
Sendai-City , 983-8, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa , 377-0, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
iBiomed Research Unit
Aguascalientes , 20121, Mexico
JM Research, SC
Cuernavaca , 62290, Mexico
Centro de Investigación Farmacéutica Especializada
Guadalajara , 44160, Mexico
Centro de Atención e Investigación Clínica en Oncología
Merida , 97134, Mexico
Hospital Universitario de Nuevo León
Monterrey , 64460, Mexico
Gelre Ziekenhuis
Apeldoorn , 7334 , Netherlands
Haga ziekenhuis
Den Haag , 2545 , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht , 3318 , Netherlands
ETZ TweeSteden
Tilburg , 5042 , Netherlands
Oslo University Hospital HF Ullevål sykehus
Oslo , 0450, Norway
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozow , 36-20, Poland
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz , 85-16, Poland
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica , 59-22, Poland
Clinical Research Center sp. z o.o MEDIC-R s.k.
Poznań , 60-84, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Emergency Hospital of Dzerzhinsk
Dzerzhinsk , 60601, Russian Federation
City clinical hospital n.a. S.P.Botkin
Moscow , 12528, Russian Federation
City Clinical Hospital # 40
Moscow , 12930, Russian Federation
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod , 60312, Russian Federation
Perm Medical Sanitary Unit#1
Perm , 61407, Russian Federation
Republican Hospital n.a.V.A.Baranov
Petrozavodsk , 18501, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39000, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
St-Petersburg , 19102, Russian Federation
Oncology Dispensary of Komi Republic
Syktyvkar , 16790, Russian Federation
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 8035, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. Infanta Leonor
Madrid , 28031, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo De Alarcon, Madrid , 28223, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Dr. Peset
Valencia , 46017, Spain
Falu Lasarett
Falun , 79182, Sweden
Sunderby Sjukhus Medicinkliniken
Luelå , 97180, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm , 141 8, Sweden
Ankara Numune Egitim ve Arastirma Hastanesi
Ankara , 06230, Turkey
Ankara University Medical Faculty
Ankara , 6100, Turkey
Trakya University Hospital
Edirne , 22030, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34093, Turkey
Erciyes University Medical Faculty
Kayseri , 38030, Turkey
On Dokuz Mayis University Medical Faculty Department of Hematology
Samsun , 55139, Turkey
Heart of England NHS Foundation Trust
Birmingham , B9 5S, United Kingdom
University Hospitals Bristol NHS Trust
Bristol , BS2 8, United Kingdom
Kent and Canterbury Hospital
Canterbury , CT1 3, United Kingdom
St Bartholomew's Hospital
London , EC1A , United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , NG5 1, 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 3

Estimated Enrollment:

390

Study ID:

NCT03301220

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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