En undersøgelse af Daratumumab
2. november 2026 opdateret af: Janssen Research & Development, LLC
Et fase 3b, Multicenter, Open-label, Daratumumab langsigtet forlængelsesstudie
The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
214
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Antwerp, Belgien, 2030
- ZAS Cadix
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Campinas, Brasilien, 13083-888
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Natal, Brasilien, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, Brasilien, 90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Rio de Janeiro, Brasilien, 20230-130
- Ministerio da Saude Instituto Nacional do Cancer
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Rio de Janeiro, Brasilien, 22775 001
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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São Paulo, Brasilien, 04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo, Brasilien, 01323 010
- Real e Benemerita Associacao Portuguesa de Beneficencia
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Aarhus N, Danmark, DK-8200
- Aarhus University Hospital
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Leeds, Det Forenede Kongerige, LS9 7TF
- St James University Hospital
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Leicester, Det Forenede Kongerige, LE1 5WW
- Leicester Royal Infirmary Haematology
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Surrey, Det Forenede Kongerige, SM2 5PT
- Royal Marsden Hospital
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Wolverhampton, Det Forenede Kongerige, WV10 0QP
- New Cross Hospital
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Comprehensive Cancer Center
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Missouri
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St Louis, Missouri, Forenede Stater, 63108
- Barnes-jewish Hospital
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New York
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Baylor University Medical Center
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Caen, Frankrig, 14033
- Centre Hospitalier Universitaire (CHU) de Caen
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Nantes, Frankrig, 44000
- CHU Nantes
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Paris, Frankrig, 75010
- Hopital Saint Louis
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Pessac, Frankrig, 33604
- Hopital Haut Leveque
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Athens Attica, Grækenland, 115 28
- Alexandra General Hospital of Athens
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Roma, Italien, 00133
- Universita Degli Studi di Roma Tor Vergata
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Roma, Italien, 00161
- Sapienza University of Rome
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Beijing, Kina, 100044
- Peking University People's Hospital
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Beijing, Kina, 100034
- Peking University First Hospital
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Beijing, Kina, 100020
- Beijing Chaoyang Hospital
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Beijing, Kina, 100006
- Peking Union Medical College Hospital
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Changchun, Kina, 130021
- The First Bethune Hospital of Jilin University
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Chengdu, Kina, 610041
- West China Hospital Si Chuan University
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Fuzhou, Kina, 350001
- Fujian Medical University
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Guangzhou, Kina, 510080
- Guangdong General Hospital
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Guangzhou, Kina, 510515
- Nanfang Hospital
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Hangzhou, Kina, 310020
- First affiliated Hospital of Zhejiang University
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Hangzhou, Kina, 310020
- First Affiliated Hospital Medical School of Zhejiang University
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Shanghai, Kina, 200003
- Shanghai Changzheng Hospital
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Shanghai, Kina, 200127
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, Kina, 200025
- Ruijin Hospital Shanghai Jiao Tong University
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Suzhou, Kina, 215002
- The First Affiliated Hospital of Soochow University
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Tianjin, Kina, 300320
- Institute of Hematology and Blood Diseases Hospital
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Tianjin, Kina, 300060
- Tianjin cancer hospital
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Wenzhou, Kina, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Zhengzhou, Kina, 450008
- Henan Cancer Hospital
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Legnica, Polen, 59-220
- Wojewodzki Szpital Specjalistyczny w Legnicy
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Poznan, Polen, 60-569
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Moscow, Rusland, 125284
- S.P. Botkin Moscow City Clinical Hospital
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Moscow, Rusland, 125284
- S.P. Botkin Moscow City Clinical Hospital 1
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Nizhny Novgorod, Rusland, 603126
- Nizhniy Novgorod Region Clinical Hospital
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Petrozavodsk, Rusland, 185019
- Republican Hospital named by V.A.Baranova
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Ryazan, Rusland, 390003
- Ryazan Regional Clinical Hospital
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Saint Petersburg, Rusland, 191024
- Clinical Research Institute of Hematology and Transfusiology
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Saint Petersburg, Rusland, 198205
- City Hospital No.15
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Saratov, Rusland, 410012
- Saratov State Medical University
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Syktyvkar, Rusland, 167904
- Oncology Dispensary of Komi Republic
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Alcorcón, Spanien, 28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona, Spanien, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spanien, 08003
- Hosp. Del Mar
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Barcelona, Spanien, 08036
- Hosp Clinic de Barcelona
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L'Hospitalet de Llobregat, Spanien, 08908
- Inst. Cat. Doncologia-H Duran I Reynals
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Madrid, Spanien, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spanien, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spanien, 28027
- Clinica Univ. de Navarra 1
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Madrid, Spanien, 28050
- Centro Integral Oncológico Clara Campal
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Murcia, Spanien, 30008
- Hosp. Gral. Univ. J.M. Morales Meseguer
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Pamplona, Spanien, 31008
- Clinica Univ. de Navarra
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Pozuelo de Alarcón, Spanien, 28223
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Spanien, 37007
- Hosp Clinico Univ de Salamanca
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San Cristóbal de La Laguna, Spanien, 38320
- Hosp. Univ. de Canarias
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Terrassa, Spanien, 08221
- Hosp. Mutua Terrassa
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Valencia, Spanien, 46017
- Hosp. Univ. Dr. Peset
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Busan, Sydkorea, 49241
- Pusan National University Hospital
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Goyang-si, Sydkorea, 10408
- National Cancer Center
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Hwasun, Sydkorea, 519-800
- Chonnam National University Hwasun Hospital
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Seongnam, Sydkorea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 03080
- Seoul National University Hospital
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Seoul, Sydkorea, 06351
- Samsung Medical Center
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Seoul, Sydkorea, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Brno, Tjekkiet, 62500
- Fakultni nemocnice Brno
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Pilsen, Tjekkiet, 304 60
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)
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Prague, Tjekkiet, 128 08
- Všeobecná fakultní nemocnice v
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Izmir, Tyrkiet (Türkiye), 35100
- Ege Universitesi Tip Fakultesi
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Chemnitz, Tyskland, 09113
- Klinikum Chemnitz gGmbH
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Hamburg, Tyskland, 22763
- Asklepios Klinik Altona
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Tübingen, Tyskland, 72076
- Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
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Cherkasy, Ukraine, 18009
- CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
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Dnipro, Ukraine, 49102
- Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
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Kharkiv, Ukraine, 61070
- MNE Regional Oncology Center
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Vinnitsa, Ukraine, 21018
- Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R&D) studies or receiving other study treatment in a Janssen R&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months
- Investigator's assessment that the benefit of continued study treatment will outweigh the risks
- A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment
- Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria:
- Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide)
- Vaccinated with an investigational vaccine (except for Coronavirus disease [COVID-19])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Daratumumab
Participants will receive a single dose of daratumumab 16 milligrams per kilograms (mg/kg) intravenous (IV) or 1800 mg subcutaneous (SC) infusion on Cycle 1 Day 1 (28-day cycle), as monotherapy or in combination with standards of care treatment (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone) or standards of care treatment alone, depending on the treatment received in the parent study. Participants who received daratumumab IV during the parent study, will have an option to switch to daratumumab SC on Day 1 of any cycle during this long-term extension study. |
Lenalidomide will be administered orally. Pomalidomide will be administered orally. Daratumumab will be administered either intravenously or subcutaneously.
Andre navne:
Carfilzomib will be administered intravenously. Dexamethasone will be administered either orally or intravenously. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants with Serious Adverse Events (SAEs)
Tidsramme: 3 years 7 months
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Number of participants with SAEs will be reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. |
3 years 7 months
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Number of Participants with AEs of Special Interest (AESI)
Tidsramme: 3 years 7 months
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Number of participants with AESI, that is, reactivation of HBV infection, will be reported. |
3 years 7 months
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Number of Participants with Pregnancies or Partner Pregnancies
Tidsramme: 3 years 7 months
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Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form. |
3 years 7 months
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Number of Participants with Abnormal Pregnancies as SAE
Tidsramme: 3 years 7 months
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Number of Participants with Abnormal Pregnancies as SAE will be reported. |
3 years 7 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. december 2022
Primær færdiggørelse (Anslået)
31. januar 2029
Studieafslutning (Anslået)
31. januar 2029
Datoer for studieregistrering
Først indsendt
24. juni 2022
Først indsendt, der opfyldte QC-kriterier
24. juni 2022
Først opslået (Faktiske)
29. juni 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, Plasmacelle
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Hæmoragiske lidelser
- Hemiske og lymfatiske sygdomme
- Myelomatose
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Carboxylsyrer
- Polycykliske forbindelser
- Piperidiner
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Phthalimider
- Phthalinsyrer
- Syrer, carbocykliske
- Piperidones
- Isoindoler
- Lenalidomid
- Dexamethason
- carfilzomib
- Pomalidomid
- Daratumumab
Andre undersøgelses-id-numre
- CR109200
- 2021-006494-33 (EudraCT nummer)
- 2022-500138-27-00 (Registry Identifier: EUCT number)
- 54767414MMY3030 (Anden identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .