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NCT03412565CompletedPhase 2

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

Source: ClinicalTrials.gov · Last updated 29 Apr 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
265 (actual)
First submitted
22 Jan 2018
Start date
26 Apr 2018
Primary completion date
12 Aug 2020
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03412565
EudraCT number
2017-004203-41

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 265
  • From 26 Apr 2018 to the primary completion date, 12 Aug 2020
  • 64 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and 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
  • Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (\<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension
  • Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[Anti-HBc\] and/or antibodies to hepatitis B surface antigen \[Anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded
  • Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy

Lab values

  • For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) \<40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmHg) or diastolic \>99 mmHg despite optimal treatment

Other

  • Exhibits clinical signs of meningeal involvement of MM

Who the study is looking for

  • Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable, secretory disease as defined by any of the following:
    • Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); or
    • Urine M-protein level \>= 200 milligram per 24 hours (mg/24 hours); or
    • Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) \>= 10 mg/dL and abnormal FLC ratio
  • Meets one of the sets of the following criteria:
    • For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
    • For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
    • D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
  • During the study, during dose interruptions, and for 3 months after receiving the last dose of any component of the study treatment, a female participant must agree not to donate eggs (ova, oocytes) and male participants of reproductive potential must not donate semen or sperm during the study, during dose interruptions, or for 3 months after the last dose of any study drug

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (64)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
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Passo FundoBrazilUnknown status
Ministerio da Saude Instituto Nacional do Cancer
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Rio de JaneiroBrazilUnknown status
Clinica Sao Germano
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São PauloBrazilUnknown status
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São PauloBrazilUnknown status
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
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São PauloBrazilUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaUnknown status
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaUnknown status
Fakultni nemocnice Ostrava
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OstravaCzechiaUnknown status
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
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PragueCzechiaUnknown status
Klinikum Chemnitz gGmbH
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ChemnitzGermanyUnknown status
Universitaetsklinikum Hamburg-Eppendorf
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HamburgGermanyUnknown status
Asklepios Klinik Altona
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HamburgGermanyUnknown status
Universitaetsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
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TübingenGermanyUnknown status
Inst. Cat. D'Oncologia-Badalona
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BadalonaSpainUnknown status
Inst. Cat. Doncologia-H Duran I Reynals
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BarcelonaSpainUnknown status
Hosp Univ Vall D Hebron
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BarcelonaSpainUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Clinica Univ. de Navarra
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MadridSpainUnknown status
Hosp. Gral. Univ. Gregorio Maranon
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MadridSpainUnknown status
Hosp. Univ. Ramon Y Cajal
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MadridSpainUnknown status
Hosp. Univ. 12 de Octubre
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MadridSpainUnknown status
Hosp. Son Llatzer
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MallorcaSpainUnknown status
Clinica Univ. de Navarra
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PamplonaSpainUnknown status
Hosp Clinico Univ de Salamanca
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SalamancaSpainUnknown status
Hosp. Univ. Dr. Peset
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ValenciaSpainUnknown status
CHU de Nantes - Hôtel Dieu
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NantesFranceUnknown status
CHU de Bordeaux - Hospital Haut-Leveque
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PessacFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
CHU Bretonneau
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ToursFranceUnknown status
CHU Nancy-Brabois
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Vandœuvre-lès-NancyFranceUnknown status
Heart of England NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Royal Bournemouth Hospital
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BournemouthUnited KingdomUnknown status
Kent and Canterbury Hospital
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CanterburyUnited KingdomUnknown status
Manchester Royal Infirmary
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ManchesterUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Galilee Medical Center
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NahariyaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
Matsuyama Red Cross Hospital
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MatsuyamaJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya CityJapanUnknown status
Billings Clinic
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BillingsUnited StatesUnknown status
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
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CharlottesvilleUnited StatesUnknown status
Karmonos Cancer Institute
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DetroitUnited StatesUnknown status
San Juan Oncology Associates
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FarmingtonUnited StatesUnknown status
Mayo Clinic in Florida
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JacksonvilleUnited StatesUnknown status
Nebraska Hematology and Oncology
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LincolnUnited StatesUnknown status
Southeast Nebraska Cancer Center
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LincolnUnited StatesUnknown status
NYU Winthrop
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MineolaUnited StatesUnknown status
Mt. Sinai School of Medicine
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New YorkUnited StatesUnknown status
Nebraska Cancer Specialists
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OmahaUnited StatesUnknown status
UF Health Cancer Center at Orlando Health
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OrlandoUnited StatesUnknown status
Utah Cancer Specialists
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Salt Lake CityUnited StatesUnknown status
Avera Medical Group - Oncology & Hematology
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Sioux FallsUnited StatesUnknown status
Providence Cancer Center
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SouthfieldUnited StatesUnknown status
Cancer Center of Central Connecticut - Southington
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SouthingtonUnited StatesUnknown status
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.