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

April 9, 2026 updated by: Janssen Research & Development, LLC

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman
      • Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Ciudad de Buenos Aires, Argentina, 1431
        • CEMIC Saavedra
      • Córdoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba
      • La Plata, Argentina, B1900
        • Hospital Italiano de La Plata
      • Rosario, Argentina, 2000
        • Sanatorio Britanico de Rosario
  • Australia
      • Heidelberg, Australia, 3150 or 3084
        • Austin Hospital
      • Waratah, Australia, 2298
        • Calvary Mater Newcastle Hospital
      • West Perth, Australia, 6005
        • The Perth Blood Institute
      • Woodville, Australia, 5011
        • Queen Elizabeth Hospital
  • Belgium
      • Antwerp, Belgium, 2060
        • ZNA
      • Bruges, Belgium, 8000
        • Algemeen Ziekenhuis Sint-Jan
      • Brussels, Belgium, 1090
        • UZBrussel
      • Ghent, Belgium, 9000
        • UZ Gent
      • Hasselt, Belgium, 3500
        • Virga Jessa Ziekenhuis
      • Kortrijk, Belgium, 8500
        • Az Groeninge
  • Brazil
      • Florianópolis, Brazil, 88034-000
        • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
      • Goiânia, Brazil, 74605-020
        • Universidade Federal de Goias - Hospital das Clinicas da UFG
      • Joinville, Brazil, 89201-260
        • Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
      • Porto Alegre, Brazil, 90035-003
        • Hospital das Clinicas de Porto Alegre
      • Rio de Janeiro, Brazil, 22775-002
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Salvador, Brazil, 41235-190
        • Hospital Sao Rafael
      • São José do Rio Preto, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
      • São Paulo, Brazil, 04122-000
        • Hospital Santa Cruz
      • São Paulo, Brazil, 01236-030
        • Instituto de Ensino e Pesquisa São Lucas
      • São Paulo, Brazil, 01455 010
        • Clinica Sao Germano
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Oshawa, Ontario, Canada, L1G-2B9
        • Lakeridge Health Oshawa
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava, Czechia, 70852
        • Fakultni Nemocnice Ostrava
      • Pilsen, Czechia, 323 00
        • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
      • Prague, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
  • Denmark
      • Aalborg, Denmark, 9000
        • Ålborg Universitetshospital
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Odense C, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Limoges, France, 87000
        • CHU de Limoges - Fédération Hépatologie
      • Lyon, France, 69002
        • Hospices Civils de Lyon HCL
      • Nantes, France, 44035
        • Chu Hotel Dieu
      • Pessac, France, 33604
        • CHU de Bordeaux - Hospital Haut-Leveque
      • Poitiers, France, 86021
        • CHU De Poitiers
      • Rennes, France, 35000
        • l Hopital Pontchaillou
      • Tours, France, 37044
        • Chu Bretonneau
  • Germany
      • Berlin, Germany, 13125
        • Helios Kliniken Berlin Buch Gmbh
      • Hamm, Germany, 59073
        • St. Barbara-Klinik Hamm GmbH
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg Medizinische Klinik V
      • Münster, Germany, 48149
        • Medizinische Klinik A
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Greece
      • Athens Attica, Greece, 115 28
        • Alexandra General Hospital of Athens
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem I.Belgyogyaszati Klinika
      • Budapest, Hungary, 1097
        • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem, I. Belgyogyaszati Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
  • Israel
      • Afula, Israel, 18101
        • Haemek
      • Ashkelon, Israel, 78741
        • Barzilai Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Haifa, Israel, 3525408
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Nahariya, Israel, 22100
        • Galilee Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant'Orsola Malpighi
      • Cagliari, Italy, 09121
        • Businco Cancer Hospital
      • Cuneo, Italy, 12100
        • A.O. Santa Croce e Carle
      • Roma, Italy, 00144
        • Ospedale S. Eugenio
      • Rome, Italy, 00161
        • Università di Roma 'La Sapienza' - Ospedale Umberto 1°
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia
      • Varese, Italy, 21100
        • ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuyama, Japan, 720-0001
        • Chugoku Central Hospital
      • Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kanazawa, Japan, 920 8641
        • Kanazawa University Hospital
      • Kawachi-Nagano, Japan, 586 8521
        • National Hospital Organization Osaka Minami Medical Center
      • Kobe, Japan, 650 0047
        • Kobe City Medical Center General Hospital
      • Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center
      • Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Kyoto, Japan, 603-8151
        • Kyoto Kuramaguchi Medical Center
      • Matsumoto, Japan, 399-8701
        • National Hospital Organization Matsumoto Medical Center
      • Matsuyama, Japan, 790-8524
        • Matsuyama Red Cross Hospital
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Sendai, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center
      • Shibukawa, Japan, 377-0280
        • National Hospital Organization Shibukawa Medical Center
      • Shibuya City, Japan, 150-8935
        • Japanese Red Cross Medical Center
  • Mexico
      • Aguascalientes, Mexico, 20121
        • iBiomed Research Unit
      • Cuernavaca, Mexico, 62290
        • JM Research, SC
      • Guadalajara, Mexico, 44160
        • Centro de Investigación Farmacéutica Especializada
      • Monterrey, Mexico, 64460
        • Hospital Universitario de Nuevo León
      • Mérida, Mexico, 97134
        • Centro de Atención e Investigación Clínica en Oncología
  • Netherlands
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuis
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • The Hague, Netherlands, 2545 AA
        • Haga ziekenhuis
      • Tilburg, Netherlands, 5042 AD
        • ETZ TweeSteden
  • Norway
      • Oslo, Norway, 0450
        • Oslo University Hospital HF Ulleval sykehus
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
      • Legnica, Poland, 59-220
        • Wojewodzki Szpital Specjalistyczny w Legnicy
      • Poznan, Poland, 61 731
        • Clinical Research Center Sp z o o Medic R Sp k
      • Warsaw, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii
  • Russia
      • Dzerzhinsk, Russia, 606019
        • Emergency Hospital of Dzerzhinsk
      • Moscow, Russia, 125284
        • City clinical hospital n.a. S.P.Botkin
      • Moscow, Russia, 129301
        • City Clinical Hospital # 40
      • Nizhny Novgorod, Russia, 603126
        • Nizhniy Novgorod Region Clinical Hospital
      • Perm, Russia, 614078
        • Perm Medical Sanitary Unit#1
      • Petrozavodsk, Russia, 185019
        • Republican Hospital n.a.V.A.Baranov
      • Ryazan, Russia, 390003
        • Ryazan Regional Clinical Hospital
      • Saint Petersburg, Russia, 191024
        • Clinical Research Institute of Hematology and Transfusiology
      • Syktyvkar, Russia, 167904
        • Oncology Dispensary of Komi Republic
  • Spain
      • Badalona, Spain, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Hosp Univ Vall D Hebron
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spain, 28031
        • Hosp. Univ. Infanta Leonor
      • Pamplona, Spain, 31008
        • Clinica Univ. de Navarra
      • Pozuelo de Alarcón, Spain, 28223
        • Hosp. Quiron Madrid Pozuelo
      • Salamanca, Spain, 37007
        • Hosp Clinico Univ de Salamanca
      • Valencia, Spain, 46017
        • Hosp. Univ. Dr. Peset
  • Sweden
      • Falun, Sweden, 79182
        • Falu Lasarett
      • Luelå, Sweden, 97180
        • Sunderby Sjukhus Medicinkliniken
      • Stockholm, Sweden, 141 86
        • Karolinska Universitetssjukhuset Huddinge
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Ankara Numune Egitim ve Arastirma Hastanesi
      • Ankara, Turkey (Türkiye), 06620
        • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
      • Edirne, Turkey (Türkiye), 22030
        • Trakya Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes Universitesi Tip Fakultesi
      • Samsun, Turkey (Türkiye), 55280
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Heart of England Nhs Foundation Trust
      • Bristol, United Kingdom, BS2 8ED
        • University Hospitals Bristol NHS Trust
      • Canterbury, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC - HAL
    • California
      • Whittier, California, United States, 90805
        • Innovative Clinical Research Inc
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • Nevada
      • North Las Vegas, Nevada, United States, 89086
        • VA Southern Nevada Healthcare
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute, Carolinas HealthCare System
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU/CHM
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology P A 1
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System
      • Tyler, Texas, United States, 75702
        • Texas Oncology P A
    • Washington
      • Seattle, Washington, United States, 90805
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Arm A: Active Monitoring
Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab.
Experimental: Arm B: Daratumumab SC
Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection 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.
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.
Other Names:
  • JNJ-54767414

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Time Frame: From randomization (Day -5) up to 77 months
PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio >=100, greater than (>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.
From randomization (Day -5) up to 77 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to Biochemical or Diagnostic (SLiM-CRAB) Progression Per Computerized Algorithm Analyses
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Overall Response Rate (ORR)
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Complete Response (CR) Rate
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Time to First-Line Treatment for Multiple Myeloma
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Progression-Free Survival on First-Line Treatment for Multiple Myeloma (PFS2)
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Best Response on First-line Therapy for Multiple Myeloma
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Overall Survival (OS)
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Percentage of Participants Who Progressed to Multiple Myeloma With Adverse Prognostic Features
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Time Frame: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Minimum Observed Serum Concentration (Cmin) of Daratumumab
Time Frame: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT( 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT( 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Number of Participants With Anti-daratumumab Antibodies
Time Frame: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Number of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
Time Frame: Cycles 1, 3, 5, 7, 12, and 24 : Predose on Day 1; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Cycles 1, 3, 5, 7, 12, and 24 : Predose on Day 1; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Time Frame: From Baseline (Day -35) up to 8 years
From Baseline (Day -35) up to 8 years
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Time Frame: From Baseline (Day -35) up to 8 years
From Baseline (Day -35) up to 8 years
Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire Score
Time Frame: From Baseline (Day -35) up to 8 years
From Baseline (Day -35) up to 8 years
Duration of Response
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years
Time to Response
Time Frame: From randomization (Day -5) up to 8 years
From randomization (Day -5) up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108172
  • 54767414SMM3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2016-001205-16 (EudraCT Number)
  • 2023-507143-11-00 (Registry Identifier: EUCT number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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