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New drug cocktail shows promise for myeloma patients ineligible for transplant

NCT ID NCT03652064

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested whether adding daratumumab to a standard three-drug regimen (bortezomib, lenalidomide, dexamethasone) helps people with newly diagnosed multiple myeloma who are not candidates for stem cell transplant. The main goal was to see if more patients achieve a deep remission with minimal residual disease. The trial enrolled 395 participants and compared the four-drug combination against the standard three drugs alone.

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 targeted antibody) added to bortezomib, lenalidomide, and dexamethasone
What this could lead to
If successful, this combination could become a new standard treatment that helps more patients achieve deep remission without needing a stem cell transplant.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. Adding daratumumab increases side effects, and long-term benefits are still being evaluated.

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

395 people

The number who actually took part.

Started

Nov 2018

Finished

Apr 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 multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria Monoclonal plasma cells in the bone marrow greater than or equal to (\>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria. CRAB criteria: 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); Renal insufficiency: creatinine clearance less than (\<) 40 milliliter per minute (mL/min) or serum creatinine \>177 micro millimoles per liter (umol/L) (\>2 mg/dL); Anemia: hemoglobin \>2 g/dL below the lower limit of normal or hemoglobin \<10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT. Biomarkers of Malignancy: Clonal bone marrow plasma cell percentage \>=60%; Involved: uninvolved serum free light chain (FLC) ratio \>=100; \>1 focal lesion on magnetic resonance imaging (MRI) studies * Must have measurable disease, as assessed by central laboratory * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing * A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen Exclusion Criteria: * Frailty index of \>=2 according to Myeloma Geriatric Assessment score * Prior therapy for multiple myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day, total of 160 mg dexamethasone or equivalent) * Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years) * Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5 * Focal radiation therapy within 14 days of randomization with the exception of palliative radiotherapy for symptomatic pain management. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • Albert Schweitzer ziekenhuis-lokatie Dordwijk

    Dordrecht, 3318 AT, Netherlands

  • Altnagelvin Hospital

    Londonderry, BT47 6SB, United Kingdom

  • Ankara University School of Medicine Cebeci Hospital

    Ankara, 06590, Turkey (Türkiye)

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Baptist MD Anderson

    Jacksonville, Florida, 32207, United States

  • Barzilai Medical Center

    Ashkelon, 78741, Israel

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR, United Kingdom

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada

  • CHU Henri Mondor

    Créteil, 94010, France

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604, France

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295, France

  • CHU de Quebec L Hotel Dieu de Quebec

    Québec, Quebec, G1J 1Z4, Canada

  • Cancer And Hematology Centers of Western Michigan PC

    Grand Rapids, Michigan, 49503, United States

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Centre Hospitalier Départmental La Roche sur Yon

    La Roche-sur-Yon, 85925, France

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20090, Poland

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Medica Sao Germano S/S LTDA

    São Paulo, 04537-081, Brazil

  • Colchester Hospital University NHS

    Colchester, CO4 5JL, United Kingdom

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340, Turkey (Türkiye)

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, 3015CE, Netherlands

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52, Czechia

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

    Pilsen, 323 00, Czechia

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46804, United States

  • Fukuoka University Hospital

    Fukuoka, 814-0180, Japan

  • Gibbs Cancer Center

    Spartanburg, South Carolina, 29303, United States

  • Good Samaritan Hospital Corvallis

    Corvallis, Oregon, 97330, United States

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010, Turkey (Türkiye)

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230, Turkey (Türkiye)

  • Hillel Yaffe Medical Center

    Hadera, 38100, Israel

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hosp. Del Mar

    Barcelona, 08003, Spain

  • Hosp. Mutua Terrassa

    Terrassa, 08221, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. Fundacion Alcorcon

    Alcorcón, 28922, Spain

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hosp. Univ. de Guadalajara

    Guadalajara, 19002, Spain

  • Hospital Santa Cruz

    São Paulo, 04122-000, Brazil

  • Innovative Clinical Research Inc

    Cerritos, California, 90703, United States

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Institut für Versorgungsforschung

    Koblenz, 56068, Germany

  • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

    São Paulo, 03102-002, Brazil

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

    Rio de Janeiro, 22775 001, Brazil

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, 01227-200, Brazil

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776, Poland

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935, Japan

  • Japanese Red Cross Osaka Hospital

    Osaka, 543 8555, Japan

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Klinikum Großhadern der Ludwig-Maximilians-Universität

    München, 81377, Germany

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047, Japan

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G-2B9, Canada

  • Leicester Royal Infirmary - Haematology

    Leicester, LE1 5WW, United Kingdom

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000, Brazil

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524, Japan

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Meir Hospital

    Kfar Saba, 44281, Israel

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20230-130, Brazil

  • Monklands District General Hospital

    Airdrie, ML6 0JS, United Kingdom

  • NSSU Szpital Uniwersytecki w Krakowie

    Krakow, 30 688, Poland

  • NYU Winthrop

    Mineola, New York, 11501, United States

  • Nagoya City University Hospital

    Nagoya, 467 8602, Japan

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • 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 Shibukawa Medical Center

    Shibukawa, 377-0280, Japan

  • New Cross Hospital

    Wolverhampton, WV10 0QP, United Kingdom

  • Norton Healthcare

    Louisville, Kentucky, 40207, United States

  • Ogaki Municipal Hospital

    Gifu, 503-8502, Japan

  • On Dokuz Mayis Universitesi Tip Fakultesi

    Samsun, 55200, Turkey (Türkiye)

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Rambam Med.Center - Hematology Institute

    Haifa, 3109601, Israel

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 900, Brazil

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Saint Lukes Hospital Saint Lukes Cancer Specialists

    Kansas City, Missouri, 64111, United States

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500, Poland

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401, United States

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Sourasky (Ichilov) Medical Center

    Tel Aviv, 64239, Israel

  • St. Josef-Krankenhaus Hamm-Bockum-Hövel

    Hamm, 59075, Germany

  • Strasbourg Oncologie Libérale

    Strasbourg, 67000, France

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734, Poland

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

    Brzozów, 36-200, Poland

  • The Gordon & Leslie Diamond Health Care Center

    Vancouver, British Columbia, V5Z 1M9, Canada

  • The Royal Oldham Hospital

    Oldham, OL1 2JH, United Kingdom

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000, Brazil

  • Universidade Estadual De Campinas

    Campinas, 13083-878, Brazil

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

    Tübingen, 72076, Germany

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitatsmedizin Leipzig

    Leipzig, 4103, Germany

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University Hospital Wales

    Cardiff, CF14 4XN, United Kingdom

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232 1301, United States

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

  • Victoria Hospital

    London, Ontario, N6A 5W9, Canada

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

    Słupsk, 76-200, Poland

  • phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg

    Aschaffenburg, 63739, Germany

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