Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a shot keep smoldering myeloma from igniting?

NCT ID NCT03301220

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested whether the drug daratumumab, given as a shot under the skin, could delay or prevent smoldering multiple myeloma from turning into active multiple myeloma. 390 people with high-risk smoldering myeloma were randomly assigned to receive daratumumab or to be watched without treatment. The main goal was to see how long it took for the disease to progress or for death to occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
daratumumab (a drug given as a shot under the skin)
What this could lead to
If it works, this could delay or prevent smoldering myeloma from turning into active multiple myeloma, potentially reducing the need for more intensive treatments later.
What could go wrong
This is a phase 3 trial, but the results may not apply to all patients. Daratumumab can cause infusion reactions, infections, and other side effects. It is not a cure, and patients may still progress to active myeloma.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

390 people

The number who actually took part.

Started

Nov 2017

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Smoldering multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Smoldering Multiple Myeloma smoldering plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoldering multiple myeloma

Contacts and locations

Locations

  • A.O. Santa Croce e Carle

    Cuneo, 12100, 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

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT, Netherlands

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28, Greece

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, 8000, Belgium

  • Ankara Numune Egitim ve Arastirma Hastanesi

    Ankara, 06230, Turkey (Türkiye)

  • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

    Ankara, 06620, Turkey (Türkiye)

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016, United States

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Austin Hospital

    Heidelberg, 3150 or 3084, Australia

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Barzilai Medical Center

    Ashkelon, 78741, Israel

  • Bnai Zion Medical Center

    Haifa, 31048, Israel

  • Businco Cancer Hospital

    Cagliari, 09121, Italy

  • CEMIC Saavedra

    Ciudad de Buenos Aires, 1431, Argentina

  • CHU Bretonneau

    Tours, 37044, France

  • CHU De Poitiers

    Poitiers, 86021, France

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604, France

  • CHU de Limoges - Fédération Hépatologie

    Limoges, 87000, France

  • Calvary Mater Newcastle Hospital

    Waratah, 2298, Australia

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Centro de Atención e Investigación Clínica en Oncología

    Mérida, 97134, Mexico

  • Centro de Investigación Farmacéutica Especializada

    Guadalajara, 44160, Mexico

  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

    Florianópolis, 88034-000, Brazil

  • Christie Hospital NHS Trust

    Manchester, M20 4BX, United Kingdom

  • Chu Hotel Dieu

    Nantes, 44035, France

  • Chugoku Central Hospital

    Fukuyama, 720-0001, Japan

  • City Clinical Hospital # 40

    Moscow, 129301, Russia

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

    Moscow, 125284, Russia

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Sao Germano

    São Paulo, 01455 010, Brazil

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Clinical Research Center Sp z o o Medic R Sp k

    Poznan, 61 731, Poland

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024, Russia

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097, Hungary

  • ETZ TweeSteden

    Tilburg, 5042 AD, Netherlands

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006, United States

  • Emergency Hospital of Dzerzhinsk

    Dzerzhinsk, 606019, Russia

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039, Turkey (Türkiye)

  • Fakultni Nemocnice Ostrava

    Ostrava, 70852, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

    Pilsen, 323 00, Czechia

  • Falu Lasarett

    Falun, 79182, Sweden

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fukuoka University Hospital

    Fukuoka, 814-0180, Japan

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

    São José do Rio Preto, 15090-000, Brazil

  • Galilee Medical Center

    Nahariya, 22100, Israel

  • Gelre Ziekenhuis

    Apeldoorn, 7334 DZ, Netherlands

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Haemek

    Afula, 18101, Israel

  • Haga ziekenhuis

    The Hague, 2545 AA, Netherlands

  • Heart of England NHS Foundation Trust

    Birmingham, B9 5SS, United Kingdom

  • Helios Kliniken Berlin Buch Gmbh

    Berlin, 13125, Germany

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. Dr. Peset

    Valencia, 46017, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospices Civils de Lyon HCL

    Lyon, 69002, France

  • Hospital Aleman

    Buenos Aires, C1118AAT, Argentina

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB, Argentina

  • Hospital Italiano de La Plata

    La Plata, B1900, Argentina

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH, Argentina

  • Hospital Santa Cruz

    São Paulo, 04122-000, Brazil

  • Hospital Sao Rafael

    Salvador, 41235-190, Brazil

  • Hospital Universitario de Nuevo León

    Monterrey, 64460, Mexico

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-003, Brazil

  • Innovative Clinical Research Inc

    Whittier, California, 90805, United States

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

    Joinville, 89201-260, Brazil

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

    Rio de Janeiro, 22775-002, Brazil

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, 01236-030, Brazil

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093, Turkey (Türkiye)

  • JM Research, SC

    Cuernavaca, 62290, Mexico

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935, Japan

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86, Sweden

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG, United Kingdom

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047, Japan

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Kyoto Kuramaguchi Medical Center

    Kyoto, 603-8151, Japan

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G-2B9, Canada

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204, United States

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524, Japan

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medizinische Klinik A

    Münster, 48149, Germany

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Nagoya City University Hospital

    Nagoya, 467 8602, Japan

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008, Japan

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586 8521, Japan

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520, Japan

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa, 377-0280, Japan

  • New York Oncology Hematology

    Albany, New York, 12206, United States

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126, Russia

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB, United Kingdom

  • OHSU/CHM

    Portland, Oregon, 97239, United States

  • Odense Universitetshospital

    Odense C, 5000, Denmark

  • Ogaki Municipal Hospital

    Gifu, 503-8502, Japan

  • Oncology Dispensary of Komi Republic

    Syktyvkar, 167904, Russia

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55280, Turkey (Türkiye)

  • Oslo University Hospital HF Ulleval sykehus

    Oslo, 0450, Norway

  • Ospedale S. Eugenio

    Roma, 00144, Italy

  • Perm Medical Sanitary Unit#1

    Perm, 614078, Russia

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138, Italy

  • Queen Elizabeth Hospital

    Woodville, 5011, Australia

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Rambam Medical Center

    Haifa, 3525408, Israel

  • Republican Hospital n.a.V.A.Baranov

    Petrozavodsk, 185019, Russia

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Ryazan Regional Clinical Hospital

    Ryazan, 390003, Russia

  • Sanatorio Britanico de Rosario

    Rosario, 2000, Argentina

  • Semmelweis Egyetem I.Belgyogyaszati Klinika

    Budapest, 1088, Hungary

  • Semmelweis Egyetem, I. Belgyogyaszati Klinika

    Budapest, 1083, Hungary

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • St. Barbara-Klinik Hamm GmbH

    Hamm, 59073, Germany

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Sunderby Sjukhus Medicinkliniken

    Luelå, 97180, Sweden

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozów, 36-200, Poland

  • Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Texas Oncology P A

    Tyler, Texas, 75702, United States

  • Texas Oncology P A 1

    Austin, Texas, 78705, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Perth Blood Institute

    West Perth, 6005, Australia

  • Trakya Universitesi Tip Fakultesi Hastanesi

    Edirne, 22030, Turkey (Türkiye)

  • UZ Gent

    Ghent, 9000, Belgium

  • UZBrussel

    Brussels, 1090, Belgium

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiânia, 74605-020, Brazil

  • Universitaetsklinikum Heidelberg Medizinische Klinik V

    Heidelberg, 69120, Germany

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

    Tübingen, 72076, Germany

  • Universitaetsklinikum Ulm

    Ulm, 89081, Germany

  • University Hospitals Bristol NHS Trust

    Bristol, BS2 8ED, United Kingdom

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Washington

    Seattle, Washington, 90805, United States

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

    Rome, 00161, Italy

  • VA North Texas Health Care System

    Dallas, Texas, 75216, United States

  • VA Southern Nevada Healthcare

    North Las Vegas, Nevada, 89086, United States

  • Virga Jessa Ziekenhuis

    Hasselt, 3500, Belgium

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

    Prague, 128 08, Czechia

  • Washington University

    St Louis, Missouri, 63110, United States

  • Wojewodzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220, Poland

  • ZNA

    Antwerp, 2060, Belgium

  • iBiomed Research Unit

    Aguascalientes, 20121, Mexico

  • l Hopital Pontchaillou

    Rennes, 35000, France

  • Ålborg Universitetshospital

    Aalborg, 9000, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.