A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma
keskiviikko 22. heinäkuuta 2026 päivittänyt: AbbVie
A Phase 3, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etentamig in Combination With Pomalidomide Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (2L+ RRMM)
Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide.
Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide.
Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
520
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: ABBVIE CALL CENTER
- Puhelinnumero: 844-663-3742
- Sähköposti: abbvieclinicaltrials@abbvie.com
Opiskelupaikat
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South Holland
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Leiden, South Holland, Alankomaat, 2333 ZA
- Leids Universitair Medisch Centrum /ID# 283142
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Rotterdam, South Holland, Alankomaat, 3015 CE
- Erasmus Medisch Centrum /ID# 283408
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New South Wales
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Wollongong, New South Wales, Australia, 2500
- Wollongong Hospital. /ID# 282694
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Queensland
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Benowa, Queensland, Australia, 4217
- Pindara Private Hospital /ID# 283010
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South Brisbane, Queensland, Australia, 4101
- Icon Cancer Care - South Brisbane /ID# 282965
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Victoria
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer Centre. /ID# 282692
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Richmond, Victoria, Australia, 3121
- Epworth Hospital - Richmond /ID# 281877
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital /ID# 281879
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital /ID# 281881
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Madrid, Espanja, 28007
- Hospital General Universitario Gregorio Maranon /ID# 283342
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Cantabria
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Santander, Cantabria, Espanja, 39008
- Hospital Universitario Marques de Valdecilla /ID# 283344
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Navarre
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Pamplona, Navarre, Espanja, 31008
- Clinica Universidad de Navarra - Pamplona /ID# 283290
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italia, 47014
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
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British Columbia
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Victoria, British Columbia, Kanada, V8R 6V5
- British Columbia Cancer Agency Vancouver Centre /ID# 282147
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Ontario
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London, Ontario, Kanada, N6A 5W9
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
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Sogn Og Fjordane
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Bergen, Sogn Og Fjordane, Norja, 5021
- Haukeland University Hospital /ID# 283524
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Braga, Portugali, 4710-243
- 2CA-Braga, Hospital de Braga /ID# 283828
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Porto, Portugali, 4200-319
- Unidade Local de Saude Sao Joao /ID# 283530
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Lisbon District
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Lisbon, Lisbon District, Portugali, 1449-005
- Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500
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Porto District
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Vila Nova de Gaia, Porto District, Portugali, 4434-502
- Unidade Local de Saude de Gaia/Espinho /ID# 283492
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Ranska, 06202
- Chu de Nice-Hopital Larchet Ii /Id# 283541
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Indre-et-Loire
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Tours, Indre-et-Loire, Ranska, 37044
- CHRU Tours - Hopital Bretonneau /ID# 281925
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Ranska, 54511
- Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Ranska, 44000
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025
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Provence-Alpes-Côte d'Azur Region
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Avignon, Provence-Alpes-Côte d'Azur Region, Ranska, 84000
- Centre Hospitalier d'Avignon /ID# 283509
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Saksa, 79106
- Universitaetsklinikum Freiburg /ID# 282874
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Karlsruhe, Baden-Wurttemberg, Saksa, 76133
- Staedtisches Klinikum Karlsruhe /ID# 283569
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Tübingen, Baden-Wurttemberg, Saksa, 72076
- Universitaetsklinikum Tuebingen /ID# 282873
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Ulm, Baden-Wurttemberg, Saksa, 89081
- Universitaetsklinikum Ulm /ID# 283884
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Bavaria
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Würzburg, Bavaria, Saksa, 97080
- Universitaetsklinikum Wuerzburg /ID# 283572
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Lower Saxony
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Hanover, Lower Saxony, Saksa, 30459
- Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Saksa, 53127
- Universitaetsklinikum Bonn /ID# 283881
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Cologne, North Rhine-Westphalia, Saksa, 50937
- Universitaetsklinikum Koeln /ID# 283930
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Kaohsiung City, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital /ID# 282970
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Vas County
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Szombathely, Vas County, Unkari, 9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
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Devon
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Plymouth, Devon, Yhdistynyt kuningaskunta, PL6 8DH
- University Hospitals Plymouth NHS Trust /ID# 283108
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Edinburgh, City of
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Edinburgh, Edinburgh, City of, Yhdistynyt kuningaskunta, EH4 2XU
- Western General Hospital - NHS Lothian /ID# 281838
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Greater London
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London, Greater London, Yhdistynyt kuningaskunta, EC1A 7BE
- St Bartholomews Hospital - Barts Health /ID# 283714
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Hampshire
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Portsmouth, Hampshire, Yhdistynyt kuningaskunta, PO6 3LY
- Queen Alexandra Hospital /ID# 281839
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North Lanarkshire
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Airdrie, North Lanarkshire, Yhdistynyt kuningaskunta, ML6 0JS
- NHS Lanarkshire /ID# 282021
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Nottinghamshire
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Nottingham, Nottinghamshire, Yhdistynyt kuningaskunta, NG5 1PB
- Nottingham City Hospital /ID# 282748
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Arizona
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Tucson, Arizona, Yhdysvallat, 85704
- University of Arizona Cancer Center /ID# 285339
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California
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Cerritos, California, Yhdysvallat, 90703
- Toi Clinical Research - Whittier /ID# 284462
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Los Angeles, California, Yhdysvallat, 90095-3075
- University of California Los Angeles /ID# 282444
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Colorado
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Aurora, Colorado, Yhdysvallat, 80045
- University Of Colorado - Anschutz Medical Campus /ID# 283478
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District of Columbia
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Washington D.C., District of Columbia, Yhdysvallat, 20007
- MedStar Georgetown University Hospital /ID# 283734
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Florida
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Weston, Florida, Yhdysvallat, 33331
- Cleveland Clinic Florida /ID# 283692
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Georgia
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Marietta, Georgia, Yhdysvallat, 30060
- Northwest Georgia Oncology Centers /ID# 284769
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Illinois
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Chicago, Illinois, Yhdysvallat, 60612
- Rush University Medical Center /ID# 283095
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Beth Israel Deaconess Medical Center /ID# 285204
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Michigan
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Grand Rapids, Michigan, Yhdysvallat, 49503
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591
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New York
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New York, New York, Yhdysvallat, 10029
- The Mount Sinai Hospital /ID# 283535
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New York, New York, Yhdysvallat, 10032
- Columbia University Medical Center /ID# 283510
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New York, New York, Yhdysvallat, 10065
- Weill Cornell Medicine - Cornell University /ID# 283712
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Rochester, New York, Yhdysvallat, 14642
- University of Rochester Medical Center /ID# 283480
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North Carolina
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Chapel Hill, North Carolina, Yhdysvallat, 27599
- University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
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Durham, North Carolina, Yhdysvallat, 27710
- Duke University Medical Center /ID# 283475
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Winston-Salem, North Carolina, Yhdysvallat, 27103
- Novant Health Forsyth Medical Center /ID# 283485
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Ohio
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Cleveland, Ohio, Yhdysvallat, 44106
- University Hospitals Cleveland Medical Center /ID# 283527
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Oregon
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Portland, Oregon, Yhdysvallat, 97239
- Oregon Health and Science University /ID# 282023
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Tennessee
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Nashville, Tennessee, Yhdysvallat, 37203
- SCRI Oncology Partners /ID# 281380
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Texas
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Houston, Texas, Yhdysvallat, 77030-4000
- MD Anderson Houston /ID# 282622
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84112
- Huntsman Cancer Institute /ID# 283512
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Virginia
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Richmond, Virginia, Yhdysvallat, 23298
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
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Wisconsin
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Madison, Wisconsin, Yhdysvallat, 53792
- University of Wisconsin Hospitals and Clinics /ID# 282516
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Inclusion Criteria:
- Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
- Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
- Adequate organ function and performance status
Exclusion Criteria:
- Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
- Known central nervous system involvement of MM
- Known history of other active malignancies within the past 3 years (with specific exceptions)
- Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
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Injection
Oral
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Kokeellinen: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
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Injection
Oral
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Active Comparator: Randomized Portion: Standard Available Therapy (SAT)
Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.
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Injektio
Injektio
Oral or Injection
Injection
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Safety Run-In: Number of Participants With Adverse Events (AE)s
Aikaikkuna: Up to Approximately 75 Months
|
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment
Aikaikkuna: Up to Approximately 75 Months
|
CR or better is defined as proportion of participants with best overall response (BOR) of CR or stringent CR (sCR) as assessed per International Myeloma Working Group (IMWG) 2016 criteria.
CR is defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates.
The treatment effect will be summarized as the difference in the CR or better rates between etentamig in combination with pomalidomide and standard available therapies (SAT).
|
Up to Approximately 75 Months
|
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Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
Aikaikkuna: Up to Approximately 75 Months
|
PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.
|
Up to Approximately 75 Months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Aikaikkuna: Up to Approximately 75 Months
|
BOR is defined as the best response achieved across all response assessments, partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR), from randomization until disease progression per investigator assessment, using IMWG (2016) response criteria.
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Up to Approximately 75 Months
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Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Aikaikkuna: Up to Approximately 12 Months
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Cmax of Etentamig.
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Up to Approximately 12 Months
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Safety Run-In: Time to Cmax (Tmax) of Etentamig
Aikaikkuna: Up to Approximately 12 Months
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Cmax of Etentamig.
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Up to Approximately 12 Months
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Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig
Aikaikkuna: Up to Approximately 12 Months
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Cmax of Etentamig.
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Up to Approximately 12 Months
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Safety Run-In: Immunogenicity of Etentamig
Aikaikkuna: Up to Approximately 75 Months
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Immunogenicity of etentamig is defined as the summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antibody (NAb)s, if NAb samples are analyzed.
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Up to Approximately 75 Months
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Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment
Aikaikkuna: Up to Approximately 75 Months
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MRDnegCR is defined as achievement of CR or better by IMWG (2016) response criteria per IRC assessment and MRD negative status as assessed by next-generation sequencing (NGS) at threshold defined in the protocol.
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Up to Approximately 75 Months
|
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Randomized Portion: Overall Survival (OS)
Aikaikkuna: Up to Approximately 75 Months
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Overall Survival (OS) is defined as the duration from the date of randomization to the date of death from any cause.
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Up to Approximately 75 Months
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Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity
Aikaikkuna: Up to Approximately 75 Months
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Sustained MRD negativity assessed in participants with relapsed/refractory multiple myeloma (RRMM).
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Up to Approximately 75 Months
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Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment
Aikaikkuna: Up to Approximately 75 Months
|
Best MRD negative CR per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
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Up to Approximately 75 Months
|
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Randomized Portion: BOR Per IRC Assessment
Aikaikkuna: Up to Approximately 75 Months
|
BOR is defined as the best response achieved across all response assessments, PR + VGPR + CR +sCR from randomization until disease progression per IRC assessment, using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
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Randomized Portion: VGPR or Better Rate Per IRC Assessment
Aikaikkuna: Up to Approximately 75 Months
|
VGPR or better rate per IRC assessment, defined as percentage of participants achieving VGPR, CR, or sCR using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
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Randomized Portion: Time to Response (TTR) Per IRC Assessment
Aikaikkuna: Up to Approximately 75 Months
|
TTR is defined as the time from randomization to first documented response (PR or better) per IRC assessment using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
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Randomized Portion: Duration of Response (DOR) Per IRC Assessment
Aikaikkuna: Up to Approximately 75 Months
|
DOR is defined as the time from first documented response (PR or better) to disease progression or death, whichever occurs first, per IRC assessment using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
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Randomized Portion: Second Progression-Free Survival (PFS2)
Aikaikkuna: Up to Approximately 75 Months
|
PFS2 is defined as time from randomization to second disease progression or death from any cause, whichever occurs first.
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Up to Approximately 75 Months
|
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Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (QoL) Score
Aikaikkuna: Up to Approximately 75 Months
|
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life score.
Patient-reported outcome (PRO) assessment.
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Up to Approximately 75 Months
|
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Randomized Portion: Event-Free Survival (EFS) Per IRC Assessment
Aikaikkuna: Up to Approximately 75 Months
|
EFS per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
|
Up to Approximately 75 Months
|
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Randomized Portion: Time to Next Treatment (TTNT)
Aikaikkuna: Up to Approximately 75 Months
|
TTNT is defined as time from randomization to initiation of next anti-myeloma therapy.
|
Up to Approximately 75 Months
|
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Randomized Portion: Time to Symptomatic Disease Progression
Aikaikkuna: Up to Approximately 75 Months
|
Time to symptomatic disease progression in participants with relapsed/refractory multiple myeloma (RRMM).
|
Up to Approximately 75 Months
|
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Randomized Portion: Change From Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma Module (EORTC QLQ-MY20)
Aikaikkuna: Up to Approximately 75 Months
|
Change from baseline in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20 .
|
Up to Approximately 75 Months
|
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Randomized Portion: Change From Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Aikaikkuna: Up to Approximately 75 Months
|
Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 (FACT-G GP5)
Aikaikkuna: Up to Approximately 75 Months
|
Overall bother due to treatment side effects as assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 FACT-G GP5.
Patient-reported outcome (PRO) assessment.
|
Up to Approximately 75 Months
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: ABBVIE INC., AbbVie
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Maanantai 30. marraskuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Tiistai 1. helmikuuta 2033
Opintojen valmistuminen (Arvioitu)
Tiistai 1. helmikuuta 2033
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 22. heinäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 22. heinäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Maanantai 27. heinäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 27. heinäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 22. heinäkuuta 2026
Viimeksi vahvistettu
Keskiviikko 1. heinäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Patologiset prosessit
- Sairauden ominaisuudet
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Hematologiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Neoplasmat, plasmasolut
- Hemostaattiset häiriöt
- Paraproteinemiat
- Veren proteiinien häiriöt
- Hemorragiset häiriöt
- Patologiset tilat, merkit ja oireet
- Hemic- ja imusuutteet
- Neoplasmat
- Toistuminen
- Multippeli myelooma
- Polisykliset yhdisteet
- Raskaat
- Raskaat
- Steroidit
- Sulatettu rengasyhdisteet
- Fluoratut steroidit
- Raskaat
- Deksametasoni
- karfiltsomibi
- pomidomidi
- daratumumabi
Muut tutkimustunnusnumerot
- M22-538
- 2026-525596-11-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
AbbVie is committed to responsible clinical trial data sharing.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD-jaon aikakehys
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-jaon käyttöoikeuskriteerit
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Joo
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