Eine Studie zu Talquetamab mit anderen Krebstherapien bei Teilnehmern mit Multiplem Myelom (MonumenTAL-2)
Eine mehrarmige Phase-1b-Studie zu Talquetamab mit anderen Krebstherapien bei Teilnehmern mit multiplem Myelom
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Fitzroy, Australien, 3065
- St Vincents Hospital Melbourne
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Melbourne, Australien, 3004
- Alfred Health
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Southport, Australien, 4215
- Gold Coast University Hospital
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Wollongong, Australien, 2500
- Wollongong Hospital
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Brussels, Belgien, 1200
- Cliniques Universitaires St-Luc
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Edegem, Belgien, 2650
- UZA
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Ghent, Belgien, 9000
- UZ Gent
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Leuven, Belgien, 3000
- UZ Leuven
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Nantes, Frankreich, 44093
- CHU Nantes
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Pessac, Frankreich, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes, Frankreich, 35000
- Chu Rennes Hopital Pontchaillou
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Toulouse, Frankreich, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Groningen, Niederlande, 9713 GZ
- UMCG
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Maastricht, Niederlande, 6229 HX
- Maastricht University Medical Centre
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Utrecht, Niederlande, 3584 CX
- UMCU
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Vereinigte Staaten, 94143
- University of California San Francisco
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Indiana University
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New Jersey
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Hackensack, New Jersey, Vereinigte Staaten, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Vereinigte Staaten, 10065
- Weill Cornell Medical College
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New York, New York, Vereinigte Staaten, 10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte, North Carolina, Vereinigte Staaten, 28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Tennessee Oncology
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Medical College Of Wisconsin
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London, Vereinigtes Königreich, W1T 7HA
- University College Hospital London
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Manchester, Vereinigtes Königreich, M20 4BX
- The Christie Nhs Foundation Trust
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Oxford, Vereinigtes Königreich, OX3 7LE
- Churchill Hospital
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Surrey, Vereinigtes Königreich, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
- A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Exclusion Criteria:
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Known to be seropositive for human immunodeficiency virus
- History of stroke or seizure within 6 months prior to the first dose of study treatment
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: Treatment Regimen A: Talquetamab + Carfilzomib
Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. |
Talquetamab will be administered subcutaneously.
Andere Namen:
Carfilzomib will be administered as an IV infusion. |
|
Experimental: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib
Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. |
Talquetamab will be administered subcutaneously.
Andere Namen:
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
|
Experimental: Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. |
Talquetamab will be administered subcutaneously.
Andere Namen:
Lenalidomide will be self-administered orally. |
|
Experimental: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. |
Talquetamab will be administered subcutaneously.
Andere Namen:
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
|
Experimental: Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. |
Talquetamab will be administered subcutaneously.
Andere Namen:
Pomalidomide will be self-administered orally. |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Zeitfenster: Up to 1 year and 10 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 1 year and 10 months
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Number of Participants with AEs by Severity
Zeitfenster: Up to 1 year and 10 months
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. |
Up to 1 year and 10 months
|
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Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Zeitfenster: Up to 1 year and 6 months
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Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. |
Up to 1 year and 6 months
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Number of Participants with Dose Limiting Toxicity (DLT)
Zeitfenster: Up to 49 days
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Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity. |
Up to 49 days
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Overall Response Rate (ORR)
Zeitfenster: Up to 1 year and 10 months
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ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria. |
Up to 1 year and 10 months
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Very Good Partial Response (VGPR) or Better Response Rate
Zeitfenster: Up to 1 year and 10 months
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VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR] + complete response [CR] +VGPR) according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Complete Response (CR) or Better Response Rate
Zeitfenster: Up to 1 year and 10 months
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CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Stringent Complete Response (sCR)
Zeitfenster: Up to 1 year and 10 months
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sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Duration of Response
Zeitfenster: Up to 1 year and 10 months
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Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first. |
Up to 1 year and 10 months
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Time to Response
Zeitfenster: Up to 1 year and 10 months
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Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. |
Up to 1 year and 10 months
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Serum Concentration of Talquetamab
Zeitfenster: Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of talquetamab. |
Up to 1 year and 10 months
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Serum Concentration of Daratumumab
Zeitfenster: Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. |
Up to 1 year and 10 months
|
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Number of Participants with Anti-Drug Antibodies to Talquetamab
Zeitfenster: Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to talquetamab will be reported. |
Up to 1 year and 10 months
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Number of Participants with Anti-Drug Antibodies to Daratumumab
Zeitfenster: Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. |
Up to 1 year and 10 months
|
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Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Zeitfenster: Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to rHuPH20 will be reported. |
Up to 1 year and 10 months
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Neubildungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Hämatologische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Neubildungen, Plasmazelle
- Hämostasestörungen
- Paraproteinämien
- Bluteiweißstörungen
- Hämorrhagische Störungen
- Hämische und lymphatische Krankheiten
- Multiples Myelom
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Carboxylsäuren
- Piperidine
- Phthalimides
- Phthalsäuren
- Säuren, carbocyclisch
- Piperidones
- Isoindolen
- Lenalidomid
- CARFILZOMIB
- Pomalidomid
- Talquetamab
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- CR108946
- 2020-004502-55 (EudraCT-Nummer)
- 64407564MMY1004 (Andere Kennung: Janssen Research & Development, LLC)
- 2023-503620-60-00 (Registrierungskennung: EUCT number)
- 2023 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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