Smoldering Multiple MyelomaPhase 3NCT03301220
A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
A Phase 3 study testing Daratumumab SC: daratumumab + rHuPH20 in people with Smoldering Multiple Myeloma, run by Janssen Research & Development, LLC at 163 sites in 24 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Multiple Myeloma
- What is being tested?
- Daratumumab SC: daratumumab + rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 163 sitesin 24 countries
- Study dates
- 7 Nov 2017to 4 May 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multiple myeloma (MM), requiring treatment, defined by any of the following:
- Bone lesions (1 or more osteolytic lesions on low-dose whole body computed tomography [LDCT], positron-emission tomography with computed tomography [PET-CT] or CT). Participants who have benign/post-traumatic bone lesions visible on screening images as well as previous imaging, may be considered for inclusion. Details (diagnosis, location, duration) on benign/post-traumatic pre-existing bone lesions that can be seen on the screening images (example [eg.], old fractures) and were also present on previous imaging are to be reported in the case report form (CRF)
- Hypercalcemia (serum calcium greater than [>]0.25 millimoles per liter [mmol/L] [>1 milligram per deciliter {mg/dL}] higher than upper limit of normal [ULN] or >2.75 mmol/L [>11 mg/dL]). Participants who have clinically stable hypercalcemia attributable to a disease other than multiple myeloma (eg, hyperparathyroidism) may be considered for inclusion after a case by case review by the medical monitor
- Renal insufficiency, preferably determined by creatinine clearance less than (<)40 milliliter per minute (mL/min) measured or estimated using the Modification of Diet in Renal Disease (MDRD), or serum creatinine >177 micromole per liter (μmol/L). Participants who have clinically stable renal insufficiency attributable to a disease other than multiple myeloma (eg, glomerulonephritis) may be considered for inclusion after a case by case review by the medical monitor
- Anemia, defined as hemoglobin <10 gram per deciliter (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
- Clonal BMPC percentage >=60%
Show all 18Show fewer
- Serum FLC ratio (involved:uninvolved) >=100 (the involved FLC must be >=100 mg/L)
- More than 1 focal lesion >=5 millimeter (mm) in diameter by magnetic resonance imaging (MRI)
- Primary systemic amyloid light-chain (AL) (immunoglobulin light chain) amyloidosis
- Exposure to any of the following:
- Prior exposure to daratumumab or prior exposure to other anti-Cluster of Differentiation 38 (anti-CD38) therapies
- Prior exposure to approved or investigational treatments for SMM or MM (including but not limited to conventional chemotherapies, immunomodulatory agent [IMiDs], or proteasome inhibitor [PIs]). Stable standard dosing of bisphosphonate and denosumab as indicated for osteoporosis is acceptable
- Exposure to investigational drug (including investigational vaccines) or invasive investigational medical device for any indication within 4 weeks or 5 half-lives, whichever is longer, before Cycle 1, Day 1
- Ongoing treatment with corticosteroids with a dose >10 milligram (mg) prednisone or equivalent per day at the time of randomization; or >280 mg cumulative prednisone dose or equivalent for any 4-week period in the year prior to randomization
- Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab), immunomodulators (eg, abatacept, methotrexate, azathioprine, cyclosporine) or other treatments that are likely to interfere with the study procedures or results
- Received treatment (chemotherapy, surgery, et cetera [etc]) for a malignancy (other than SMM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion), which is considered cured with minimal risk of recurrence within 3 years
- Medical or psychiatric condition or disease (for example, active systemic disease [including presence of auto-antibodies], uncontrolled diabetes) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
- Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies, hyaluronidase, or other human proteins, or their excipients, or known sensitivity to mammalian-derived products (including dairy allergy)
Trial locations and contacts
163 sites in 24 countries.
163 sites in 24 countries
United States23 sites
New York Oncology Hematology
Albany, New York, 12206
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Texas Oncology P A 1
Austin, Texas, 78705
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, 28204
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
VA North Texas Health Care System
Dallas, Texas, 75216
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
East Jefferson General Hospital
Metairie, Louisiana, 70006
Miami Cancer Institute
Miami, Florida, 33176
VA Southern Nevada Healthcare
North Las Vegas, Nevada, 89086
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016
OHSU/CHM
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 90805
Washington University
St Louis, Missouri, 63110
Stony Brook University Medical Center
Stony Brook, New York, 11794
Texas Oncology P A
Tyler, Texas, 75702
Innovative Clinical Research Inc
Whittier, California, 90805
Japan18 sites
Fukuoka University Hospital
Fukuoka, 814-0180
Chugoku Central Hospital
Fukuyama, 720-0001
Ogaki Municipal Hospital
Gifu, 503-8502
Kagoshima University Hospital
Kagoshima, 890-8520
Kanazawa University Hospital
Kanazawa, 920 8641
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586 8521
Kobe City Medical Center General Hospital
Kobe, 650 0047
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
Kurume University Hospital
Kurume, 830-0011
Kyoto Kuramaguchi Medical Center
Kyoto, 603-8151
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701
Matsuyama Red Cross Hospital
Matsuyama, 790-8524
Nagoya City University Hospital
Nagoya, 467 8602
Niigata Cancer Center Hospital
Niigata, 951-8566
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
National Hospital Organization Shibukawa Medical Center
Shibukawa, 377-0280
Japanese Red Cross Medical Center
Shibuya City, 150-8935
Brazil10 sites
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, 88034-000
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, 74605-020
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Joinville, 89201-260
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-003
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775-002
Hospital Sao Rafael
Salvador, 41235-190
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090-000
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01236-030
Clinica Sao Germano
São Paulo, 01455 010
Hospital Santa Cruz
São Paulo, 04122-000
Israel10 sites
Haemek
Afula, 18101
Barzilai Medical Center
Ashkelon, 78741
Bnai Zion Medical Center
Haifa, 31048
Carmel Medical Center
Haifa, 3436212
Rambam Medical Center
Haifa, 3525408
Hadassah Medical Center
Jerusalem, 9112001
Galilee Medical Center
Nahariya, 22100
Rabin Medical Center
Petah Tikva, 49100
Sheba Medical Center
Ramat Gan, 52621
Sourasky Medical Center
Tel Aviv, 6423906
Spain10 sites
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp Clinic de Barcelona
Barcelona, 08036
Hosp Univ Vall D Hebron
Barcelona, 8035
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Hosp. Univ. Infanta Leonor
Madrid, 28031
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Clinica Univ. de Navarra
Pamplona, 31008
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Hosp. Univ. Dr. Peset
Valencia, 46017
Russia9 sites
Emergency Hospital of Dzerzhinsk
Dzerzhinsk, 606019
City clinical hospital n.a. S.P.Botkin
Moscow, 125284
City Clinical Hospital # 40
Moscow, 129301
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod, 603126
Perm Medical Sanitary Unit#1
Perm, 614078
Republican Hospital n.a.V.A.Baranov
Petrozavodsk, 185019
Ryazan Regional Clinical Hospital
Ryazan, 390003
Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, 191024
Oncology Dispensary of Komi Republic
Syktyvkar, 167904
France7 sites
CHU de Limoges - Fédération Hépatologie
Limoges, 87000
Hospices Civils de Lyon HCL
Lyon, 69002
Chu Hotel Dieu
Nantes, 44035
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604
CHU De Poitiers
Poitiers, 86021
l Hopital Pontchaillou
Rennes, 35000
CHU Bretonneau
Tours, 37044
Italy7 sites
Policlinico Sant'Orsola Malpighi
Bologna, 40138
Businco Cancer Hospital
Cagliari, 09121
A.O. Santa Croce e Carle
Cuneo, 12100
Ospedale S. Eugenio
Roma, 00144
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
Rome, 00161
A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia
Torino, 10126
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
Varese, 21100
United Kingdom7 sites
Heart of England NHS Foundation Trust
Birmingham, B9 5SS
University Hospitals Bristol NHS Trust
Bristol, BS2 8ED
Kent and Canterbury Hospital
Canterbury, CT1 3NG
St Bartholomew's Hospital
London, EC1A 7BE
Christie Hospital NHS Trust
Manchester, M20 4BX
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Argentina6 sites
Hospital Aleman
Buenos Aires, C1118AAT
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
CEMIC Saavedra
Ciudad de Buenos Aires, 1431
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH
Hospital Italiano de La Plata
La Plata, B1900
Sanatorio Britanico de Rosario
Rosario, 2000
Belgium6 sites
ZNA
Antwerp, 2060
Algemeen Ziekenhuis Sint-Jan
Bruges, 8000
UZBrussel
Brussels, 1090
UZ Gent
Ghent, 9000
Virga Jessa Ziekenhuis
Hasselt, 3500
Az Groeninge
Kortrijk, 8500
Germany6 sites
Helios Kliniken Berlin Buch Gmbh
Berlin, 13125
St. Barbara-Klinik Hamm GmbH
Hamm, 59073
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg, 69120
Medizinische Klinik A
Münster, 48149
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, 72076
Universitaetsklinikum Ulm
Ulm, 89081
Turkey (Türkiye)6 sites
Ankara Numune Egitim ve Arastirma Hastanesi
Ankara, 06230
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, 06620
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, 22030
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093
Erciyes Universitesi Tip Fakultesi
Kayseri, 38039
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55280
Mexico5 sites
iBiomed Research Unit
Aguascalientes, 20121
JM Research, SC
Cuernavaca, 62290
Centro de Investigación Farmacéutica Especializada
Guadalajara, 44160
Centro de Atención e Investigación Clínica en Oncología
Mérida, 97134
Hospital Universitario de Nuevo León
Monterrey, 64460
Poland5 sites
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36-200
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica, 59-220
Clinical Research Center Sp z o o Medic R Sp k
Poznan, 61 731
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776
Australia4 sites
Austin Hospital
Heidelberg, 3150 or 3084
Calvary Mater Newcastle Hospital
Waratah, 2298
The Perth Blood Institute
West Perth, 6005
Queen Elizabeth Hospital
Woodville, 5011
Czechia4 sites
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni Nemocnice Ostrava
Ostrava, 70852
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Pilsen, 323 00
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Prague, 128 08
Denmark4 sites
Ålborg Universitetshospital
Aalborg, 9000
Aarhus University Hospital
Aarhus N, 8200
Rigshospitalet
Copenhagen, 2100
Odense Universitetshospital
Odense C, 5000
Hungary4 sites
Semmelweis Egyetem, I. Belgyogyaszati Klinika
Budapest, 1083
Semmelweis Egyetem I.Belgyogyaszati Klinika
Budapest, 1088
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, 1097
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Netherlands4 sites
Gelre Ziekenhuis
Apeldoorn, 7334 DZ
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT
Haga ziekenhuis
The Hague, 2545 AA
ETZ TweeSteden
Tilburg, 5042 AD
Canada3 sites
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Lakeridge Health Oshawa
Oshawa, Ontario, L1G-2B9
Sweden3 sites
Falu Lasarett
Falun, 79182
Sunderby Sjukhus Medicinkliniken
Luelå, 97180
Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86
About this study
Official title: 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).
- Conditions
- Smoldering Multiple Myeloma
- Being tested
- Daratumumab SC: daratumumab + rHuPH20
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab SC: daratumumab + rHuPH20Drug
Also called JNJ-54767414
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Active Monitoring | No intervention | 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. |
| Arm B: Daratumumab SC | Experimental | 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. Receives: Drug: Daratumumab SC: daratumumab + rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
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.
Measured: From randomization (Day -5) up to 77 months
Secondary outcomes (17)
Time to Biochemical or Diagnostic (SLiM-CRAB) Progression Per Computerized Algorithm Analyses
Measured: From randomization (Day -5) up to 8 years
Overall Response Rate (ORR)
Measured: From randomization (Day -5) up to 8 years
Complete Response (CR) Rate
Measured: From randomization (Day -5) up to 8 years
Time to First-Line Treatment for Multiple Myeloma
Measured: From randomization (Day -5) up to 8 years
Progression-Free Survival on First-Line Treatment for Multiple Myeloma (PFS2)
Measured: From randomization (Day -5) up to 8 years
Best Response on First-line Therapy for Multiple Myeloma
Measured: From randomization (Day -5) up to 8 years
Overall Survival (OS)
Measured: From randomization (Day -5) up to 8 years
Percentage of Participants Who Progressed to Multiple Myeloma With Adverse Prognostic Features
Measured: From randomization (Day -5) up to 8 years
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Baseline (Day -35) up to 8 years
Duration of Response
Measured: From randomization (Day -5) up to 8 years
Time to Response
Measured: From randomization (Day -5) up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start7 Nov 2017
- Primary completion1 May 2024
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoldering Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301220
- Sponsor's protocol ID
- CR108172
- Other IDs
- 54767414SMM3001, 2016-001205-16, 2023-507143-11-00, 2023, 2016
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2017
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Suzuki K, Kosugi H, Ito T, Takamatsu Y, Voorhees PM, Rajkumar SV, Ito M, Sakai C, Takahashi M, Nakatogawa T, Dennis R, Carson R, Dimopoulos MA. Japanese subgroup analysis of AQUILA trial: daratumumab vs active monitoring in high-risk smoldering multiple myeloma. Jpn J Clin Oncol. 2026 Sep 16:hyag146. doi: 10.1093/jjco/hyag146. Online ahead of print.
PubMed 42747040Dimopoulos MA, Voorhees PM, Schjesvold F, Cohen YC, Hungria V, Sandhu I, Lindsay J, Baker RI, Suzuki K, Kosugi H, Levin MD, Beksac M, Stockerl-Goldstein K, Oriol A, Mikala G, Garate G, Theunissen K, Spicka I, Mylin AK, Bringhen S, Uttervall K, Pula B, Medvedova E, Cowan AJ, Moreau P, Mateos MV, Goldschmidt H, Ahmadi T, Sha L, Cortoos A, Katz EG, Rousseau E, Li L, Dennis RM, Carson R, Rajkumar SV; AQUILA Investigators. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. N Engl J Med. 2025 May 8;392(18):1777-1788. doi: 10.1056/NEJMoa2409029. Epub 2024 Dec 9.
PubMed 39652675