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ACTIVE NOT RECRUITING

NCT03301220

PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2017-11-07

Completion Date

2026-06-30

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Smoldering Multiple Myeloma

Interventions

DRUG

Daratumumab SC: daratumumab + rHuPH20

Participants will receive daratumumab SC injection (daratumumab 1800 mg + rHuPH20 \[2000 U/mL\]) once weekly for Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks for Cycle 3 to Cycle 6 (Days 1 and 15), and thereafter every 4 weeks (Day 1) until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. Each cycle is 28 days in duration.

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: 1. 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) 2. 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 3. 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 4. Anemia, defined as hemoglobin \<10 gram per deciliter (g/dL) 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 5. Clonal BMPC percentage \>=60% 6. Serum FLC ratio (involved:uninvolved) \>=100 (the involved FLC must be \>=100 mg/L) 7. 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: 1. Prior exposure to daratumumab or prior exposure to other anti-Cluster of Differentiation 38 (anti-CD38) therapies 2. 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 3. 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 4. 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 5. 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)

Locations (163)

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Innovative Clinical Research Inc

Whittier, California, United States

Miami Cancer Institute

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

VA Southern Nevada Healthcare

North Las Vegas, Nevada, United States

New York Oncology Hematology

Albany, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

OHSU/CHM

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Texas Oncology P A

Austin, Texas, United States

VA North Texas Health Care System

Dallas, Texas, United States

Texas Oncology P A

Tyler, Texas, United States

University of Washington

Seattle, Washington, United States

Hospital Aleman

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

CEMIC Saavedra

Ciudad de Buenos Aires, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Sanatorio Britanico de Rosario

Rosario, Argentina

Austin Hospital

Heidelberg, Australia

Calvary Mater Newcastle Hospital

Waratah, Australia

The Perth Blood Institute

West Perth, Australia

Queen Elizabeth Hospital

Woodville, Australia

ZNA

Antwerp, Belgium

Algemeen Ziekenhuis Sint-Jan

Bruges, Belgium

UZBrussel

Brussels, Belgium

UZ Gent

Ghent, Belgium

Virga Jessa Ziekenhuis

Hasselt, Belgium

Az Groeninge

Kortrijk, Belgium

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, Brazil

Universidade Federal de Goias - Hospital das Clinicas da UFG

Goiânia, Brazil

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, Brazil

Hospital Sao Rafael

Salvador, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, Brazil

Instituto de Ensino e Pesquisa São Lucas

São Paulo, Brazil

Clinica Sao Germano

São Paulo, Brazil

Hospital Santa Cruz

São Paulo, Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni Nemocnice Ostrava

Ostrava, Czechia

Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

Pilsen, Czechia

Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

Prague, Czechia

Ålborg Universitetshospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense Universitetshospital

Odense C, Denmark

CHU de Limoges - Fédération Hépatologie

Limoges, France

Hospices Civils de Lyon HCL

Lyon, France

Chu Hotel Dieu

Nantes, France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, France

CHU De Poitiers

Poitiers, France

l Hopital Pontchaillou

Rennes, France

CHU Bretonneau

Tours, France

Helios Kliniken Berlin Buch Gmbh

Berlin, Germany

St. Barbara-Klinik Hamm GmbH

Hamm, Germany

Universitaetsklinikum Heidelberg Medizinische Klinik V

Heidelberg, Germany

Medizinische Klinik A

Münster, Germany

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tübingen, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Alexandra General Hospital of Athens

Athens Attica, Greece

Semmelweis Egyetem, I. Belgyogyaszati Klinika

Budapest, Hungary

Semmelweis Egyetem I.Belgyogyaszati Klinika

Budapest, Hungary

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Haemek

Afula, Israel

Barzilai Medical Center

Ashkelon, Israel

Bnai Zion Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Rambam Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Galilee Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Sourasky Medical Center

Tel Aviv, Israel

Policlinico Sant'Orsola Malpighi

Bologna, Italy

Businco Cancer Hospital

Cagliari, Italy

A.O. Santa Croce e Carle

Cuneo, Italy

Ospedale S. Eugenio

Roma, Italy

Università di Roma 'La Sapienza' - Ospedale Umberto 1°

Rome, Italy

A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia

Torino, Italy

ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi

Varese, Italy

Fukuoka University Hospital

Fukuoka, Japan

Chugoku Central Hospital

Fukuyama, Japan

Ogaki Municipal Hospital

Gifu, Japan

Kagoshima University Hospital

Kagoshima, Japan

Kanazawa University Hospital

Kanazawa, Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Kurume University Hospital

Kurume, Japan

Kyoto Kuramaguchi Medical Center

Kyoto, Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto, Japan

Matsuyama Red Cross Hospital

Matsuyama, Japan

Nagoya City University Hospital

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

National Hospital Organization Sendai Medical Center

Sendai, Japan

National Hospital Organization Shibukawa Medical Center

Shibukawa, Japan

Japanese Red Cross Medical Center

Shibuya City, Japan

iBiomed Research Unit

Aguascalientes, Mexico

JM Research, SC

Cuernavaca, Mexico

Centro de Investigación Farmacéutica Especializada

Guadalajara, Mexico

Centro de Atención e Investigación Clínica en Oncología

Mérida, Mexico

Hospital Universitario de Nuevo León

Monterrey, Mexico

Gelre Ziekenhuis

Apeldoorn, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Haga ziekenhuis

The Hague, Netherlands

ETZ TweeSteden

Tilburg, Netherlands

Oslo University Hospital HF Ulleval sykehus

Oslo, Norway

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, Poland

Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

Bydgoszcz, Poland

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, Poland

Clinical Research Center Sp z o o Medic R Sp k

Poznan, Poland

Instytut Hematologii i Transfuzjologii

Warsaw, Poland

Emergency Hospital of Dzerzhinsk

Dzerzhinsk, Russia

City clinical hospital n.a. S.P.Botkin

Moscow, Russia

City Clinical Hospital # 40

Moscow, Russia

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, Russia

Perm Medical Sanitary Unit#1

Perm, Russia

Republican Hospital n.a.V.A.Baranov

Petrozavodsk, Russia

Ryazan Regional Clinical Hospital

Ryazan, Russia

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, Russia

Oncology Dispensary of Komi Republic

Syktyvkar, Russia

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. Infanta Leonor

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. Dr. Peset

Valencia, Spain

Falu Lasarett

Falun, Sweden

Sunderby Sjukhus Medicinkliniken

Luelå, Sweden

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Ankara Numune Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

Ankara, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi Hastanesi

Edirne, Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi

Kayseri, Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, Turkey (Türkiye)

Heart of England NHS Foundation Trust

Birmingham, United Kingdom

University Hospitals Bristol NHS Trust

Bristol, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

Christie Hospital NHS Trust

Manchester, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (163)