Uno studio di Talquetamab con altre terapie antitumorali nei partecipanti con mieloma multiplo (MonumenTAL-2)
Uno studio multi-braccio di fase 1b su talquetamab con altre terapie antitumorali nei partecipanti con mieloma multiplo
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Fitzroy, Australia, 3065
- St Vincents Hospital Melbourne
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Melbourne, Australia, 3004
- Alfred Health
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Southport, Australia, 4215
- Gold Coast University Hospital
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Wollongong, Australia, 2500
- Wollongong Hospital
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Brussels, Belgio, 1200
- Cliniques Universitaires St-Luc
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Edegem, Belgio, 2650
- UZA
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Ghent, Belgio, 9000
- UZ Gent
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Leuven, Belgio, 3000
- UZ Leuven
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Nantes, Francia, 44093
- CHU Nantes
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Pessac, Francia, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes, Francia, 35000
- Chu Rennes Hopital Pontchaillou
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Toulouse, Francia, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Groningen, Olanda, 9713 GZ
- UMCG
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Maastricht, Olanda, 6229 HX
- Maastricht University Medical Centre
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Utrecht, Olanda, 3584 CX
- UMCU
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London, Regno Unito, W1T 7HA
- University College Hospital London
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Manchester, Regno Unito, M20 4BX
- The Christie Nhs Foundation Trust
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Oxford, Regno Unito, OX3 7LE
- Churchill Hospital
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Surrey, Regno Unito, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Stati Uniti, 94143
- University of California San Francisco
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Colorado
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Denver, Colorado, Stati Uniti, 80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Stati Uniti, 10065
- Weill Cornell Medical College
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New York, New York, Stati Uniti, 10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- Tennessee Oncology
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Medical College Of Wisconsin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
Carfilzomib will be administered as an IV infusion. |
|
Sperimentale: 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.
Altri nomi:
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
|
Sperimentale: 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.
Altri nomi:
Lenalidomide will be self-administered orally. |
|
Sperimentale: 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.
Altri nomi:
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
|
Sperimentale: 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.
Altri nomi:
Pomalidomide will be self-administered orally. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Response Rate (ORR)
Lasso di tempo: Up to 1 year and 10 months
|
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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Stringent Complete Response (sCR)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Neoplasie, plasmacellule
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Disturbi emorragici
- Malattie emiche e linfatiche
- Mieloma multiplo
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Acidi carbossilici
- Piperidine
- Ftalimides
- Acidi ftalici
- Acidi, carbociclico
- Piperidoni
- Isoindoli
- Lenalidomide
- carfilzomib
- pomalidomide
- Talquetamab
Altri numeri di identificazione dello studio
- CR108946
- 2020-004502-55 (Numero EudraCT)
- 64407564MMY1004 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-503620-60-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
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