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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

22. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

520

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Australien
    • New South Wales
      • Wollongong, New South Wales, Australien, 2500
        • Wollongong Hospital. /ID# 282694
    • Queensland
      • Benowa, Queensland, Australien, 4217
        • Pindara Private Hospital /ID# 283010
      • South Brisbane, Queensland, Australien, 4101
        • Icon Cancer Care - South Brisbane /ID# 282965
    • Victoria
      • Melbourne, Victoria, Australien, 3000
        • Peter MacCallum Cancer Centre. /ID# 282692
      • Richmond, Victoria, Australien, 3121
        • Epworth Hospital - Richmond /ID# 281877
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
        • Fiona Stanley Hospital /ID# 281879
      • Nedlands, Western Australia, Australien, 6009
        • Sir Charles Gairdner Hospital /ID# 281881
  • Deutschland
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Deutschland, 79106
        • Universitaetsklinikum Freiburg /ID# 282874
      • Karlsruhe, Baden-Wurttemberg, Deutschland, 76133
        • Staedtisches Klinikum Karlsruhe /ID# 283569
      • Tübingen, Baden-Wurttemberg, Deutschland, 72076
        • Universitaetsklinikum Tuebingen /ID# 282873
      • Ulm, Baden-Wurttemberg, Deutschland, 89081
        • Universitaetsklinikum Ulm /ID# 283884
    • Bavaria
      • Würzburg, Bavaria, Deutschland, 97080
        • Universitaetsklinikum Wuerzburg /ID# 283572
    • Lower Saxony
      • Hanover, Lower Saxony, Deutschland, 30459
        • Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Deutschland, 53127
        • Universitaetsklinikum Bonn /ID# 283881
      • Cologne, North Rhine-Westphalia, Deutschland, 50937
        • Universitaetsklinikum Koeln /ID# 283930
  • Frankreich
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankreich, 06202
        • Chu de Nice-Hopital Larchet Ii /Id# 283541
    • Indre-et-Loire
      • Tours, Indre-et-Loire, Frankreich, 37044
        • CHRU Tours - Hopital Bretonneau /ID# 281925
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankreich, 54511
        • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, Frankreich, 44000
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025
    • Provence-Alpes-Côte d'Azur Region
      • Avignon, Provence-Alpes-Côte d'Azur Region, Frankreich, 84000
        • Centre Hospitalier d'Avignon /ID# 283509
  • Italien
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italien, 47014
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
  • Kanada
    • British Columbia
      • Victoria, British Columbia, Kanada, V8R 6V5
        • British Columbia Cancer Agency Vancouver Centre /ID# 282147
    • Ontario
      • London, Ontario, Kanada, N6A 5W9
        • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
  • Niederlande
    • South Holland
      • Leiden, South Holland, Niederlande, 2333 ZA
        • Leids Universitair Medisch Centrum /ID# 283142
      • Rotterdam, South Holland, Niederlande, 3015 CE
        • Erasmus Medisch Centrum /ID# 283408
  • Norwegen
    • Sogn Og Fjordane
      • Bergen, Sogn Og Fjordane, Norwegen, 5021
        • Haukeland University Hospital /ID# 283524
  • Portugal
      • Braga, Portugal, 4710-243
        • 2CA-Braga, Hospital de Braga /ID# 283828
      • Porto, Portugal, 4200-319
        • Unidade Local de Saude Sao Joao /ID# 283530
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1449-005
        • Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Unidade Local de Saude de Gaia/Espinho /ID# 283492
  • Spanien
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 283342
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 283344
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 283290
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 282970
  • Ungarn
    • Vas County
      • Szombathely, Vas County, Ungarn, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
  • Vereinigte Staaten
    • Arizona
      • Tucson, Arizona, Vereinigte Staaten, 85704
        • University of Arizona Cancer Center /ID# 285339
    • California
      • Cerritos, California, Vereinigte Staaten, 90703
        • Toi Clinical Research - Whittier /ID# 284462
      • Los Angeles, California, Vereinigte Staaten, 90095-3075
        • University of California Los Angeles /ID# 282444
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • University Of Colorado - Anschutz Medical Campus /ID# 283478
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20007
        • MedStar Georgetown University Hospital /ID# 283734
    • Florida
      • Weston, Florida, Vereinigte Staaten, 33331
        • Cleveland Clinic Florida /ID# 283692
    • Georgia
      • Marietta, Georgia, Vereinigte Staaten, 30060
        • Northwest Georgia Oncology Centers /ID# 284769
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Rush University Medical Center /ID# 283095
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02215
        • Beth Israel Deaconess Medical Center /ID# 285204
    • Michigan
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • The Mount Sinai Hospital /ID# 283535
      • New York, New York, Vereinigte Staaten, 10032
        • Columbia University Medical Center /ID# 283510
      • New York, New York, Vereinigte Staaten, 10065
        • Weill Cornell Medicine - Cornell University /ID# 283712
      • Rochester, New York, Vereinigte Staaten, 14642
        • University of Rochester Medical Center /ID# 283480
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Duke University Medical Center /ID# 283475
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27103
        • Novant Health Forsyth Medical Center /ID# 283485
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44106
        • University Hospitals Cleveland Medical Center /ID# 283527
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Oregon Health and Science University /ID# 282023
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37203
        • SCRI Oncology Partners /ID# 281380
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030-4000
        • MD Anderson Houston /ID# 282622
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84112
        • Huntsman Cancer Institute /ID# 283512
    • Virginia
      • Richmond, Virginia, Vereinigte Staaten, 23298
        • VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • University of Wisconsin Hospitals and Clinics /ID# 282516
  • Vereinigtes Königreich
    • Devon
      • Plymouth, Devon, Vereinigtes Königreich, PL6 8DH
        • University Hospitals Plymouth NHS Trust /ID# 283108
    • Edinburgh, City of
      • Edinburgh, Edinburgh, City of, Vereinigtes Königreich, EH4 2XU
        • Western General Hospital - NHS Lothian /ID# 281838
    • Greater London
      • London, Greater London, Vereinigtes Königreich, EC1A 7BE
        • St Bartholomews Hospital - Barts Health /ID# 283714
    • Hampshire
      • Portsmouth, Hampshire, Vereinigtes Königreich, PO6 3LY
        • Queen Alexandra Hospital /ID# 281839
    • North Lanarkshire
      • Airdrie, North Lanarkshire, Vereinigtes Königreich, ML6 0JS
        • NHS Lanarkshire /ID# 282021
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Vereinigtes Königreich, NG5 1PB
        • Nottingham City Hospital /ID# 282748

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Arzneimittel: Etentamig
Injection
Arzneimittel: Pomalidomide
Oral
Experimental: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Arzneimittel: Etentamig
Injection
Arzneimittel: Pomalidomide
Oral
Aktiver Komparator: 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.
Arzneimittel: Daratumumab
Injektion
Arzneimittel: Carfilzomib
Injektion
Arzneimittel: Dexamethasone
Oral or Injection
Arzneimittel: Teclistamab
Injection

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety Run-In: Number of Participants With Adverse Events (AE)s
Zeitfenster: 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
Zeitfenster: 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
Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Zeitfenster: 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.
Up to Approximately 75 Months
Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Zeitfenster: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Time to Cmax (Tmax) of Etentamig
Zeitfenster: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig
Zeitfenster: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Immunogenicity of Etentamig
Zeitfenster: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment
Zeitfenster: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: Overall Survival (OS)
Zeitfenster: Up to Approximately 75 Months
Overall Survival (OS) is defined as the duration from the date of randomization to the date of death from any cause.
Up to Approximately 75 Months
Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity
Zeitfenster: Up to Approximately 75 Months
Sustained MRD negativity assessed in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment
Zeitfenster: Up to Approximately 75 Months
Best MRD negative CR per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
Randomized Portion: BOR Per IRC Assessment
Zeitfenster: 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
Randomized Portion: VGPR or Better Rate Per IRC Assessment
Zeitfenster: 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
Randomized Portion: Time to Response (TTR) Per IRC Assessment
Zeitfenster: 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
Randomized Portion: Duration of Response (DOR) Per IRC Assessment
Zeitfenster: 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
Randomized Portion: Second Progression-Free Survival (PFS2)
Zeitfenster: Up to Approximately 75 Months
PFS2 is defined as time from randomization to second disease progression or death from any cause, whichever occurs first.
Up to Approximately 75 Months
Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (QoL) Score
Zeitfenster: 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.
Up to Approximately 75 Months
Randomized Portion: Event-Free Survival (EFS) Per IRC Assessment
Zeitfenster: Up to Approximately 75 Months
EFS per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
Randomized Portion: Time to Next Treatment (TTNT)
Zeitfenster: Up to Approximately 75 Months
TTNT is defined as time from randomization to initiation of next anti-myeloma therapy.
Up to Approximately 75 Months
Randomized Portion: Time to Symptomatic Disease Progression
Zeitfenster: Up to Approximately 75 Months
Time to symptomatic disease progression in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
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)
Zeitfenster: 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
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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AbbVie

Ermittler

  • Studienleiter: ABBVIE INC., AbbVie

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. November 2026

Primärer Abschluss (Geschätzt)

1. Februar 2033

Studienabschluss (Geschätzt)

1. Februar 2033

Studienanmeldedaten

Zuerst eingereicht

22. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juli 2026

Zuerst gepostet (Tatsächlich)

27. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • M22-538
  • 2026-525596-11-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD-Sharing-Zugriffskriterien

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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