Studie talquetamabu s jinými protirakovinnými terapiemi u účastníků s mnohočetným myelomem (MonumenTAL-2)
Víceramenná studie fáze 1b talquetamabu s dalšími protinádorovými terapiemi u účastníků s mnohočetným myelomem
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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Fitzroy, Austrálie, 3065
- St Vincents Hospital Melbourne
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Melbourne, Austrálie, 3004
- Alfred Health
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Southport, Austrálie, 4215
- Gold Coast University Hospital
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Wollongong, Austrálie, 2500
- Wollongong Hospital
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Brussels, Belgie, 1200
- Cliniques Universitaires St-Luc
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Edegem, Belgie, 2650
- UZA
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Ghent, Belgie, 9000
- UZ Gent
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Leuven, Belgie, 3000
- UZ Leuven
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Nantes, Francie, 44093
- CHU Nantes
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Pessac, Francie, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes, Francie, 35000
- Chu Rennes Hopital Pontchaillou
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Toulouse, Francie, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Groningen, Holandsko, 9713 GZ
- UMCG
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Maastricht, Holandsko, 6229 HX
- Maastricht University Medical Centre
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Utrecht, Holandsko, 3584 CX
- UMCU
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London, Spojené království, W1T 7HA
- University College Hospital London
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Manchester, Spojené království, M20 4BX
- The Christie Nhs Foundation Trust
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Oxford, Spojené království, OX3 7LE
- Churchill Hospital
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Surrey, Spojené království, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Spojené státy, 94143
- University of California San Francisco
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Colorado
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Denver, Colorado, Spojené státy, 80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana University
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Spojené státy, 10065
- Weill Cornell Medical College
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New York, New York, Spojené státy, 10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Spojené státy, 37203
- Tennessee Oncology
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Wisconsin
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College Of Wisconsin
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
Ostatní jména:
Carfilzomib will be administered as an IV infusion. |
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Experimentální: 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.
Ostatní jména:
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
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Experimentální: 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.
Ostatní jména:
Lenalidomide will be self-administered orally. |
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Experimentální: 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.
Ostatní jména:
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
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Experimentální: 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.
Ostatní jména:
Pomalidomide will be self-administered orally. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Overall Response Rate (ORR)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Novotvary
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Hematologická onemocnění
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Novotvary, plazmatické buňky
- Hemostatické poruchy
- Paraproteinémie
- Poruchy krevních bílkovin
- Hemoragické poruchy
- Hemická a lymfatická onemocnění
- Mnohočetný myelom
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Karboxylové kyseliny
- Piperidiny
- Fthalimidy
- Kyseliny ftalové
- Kyseliny, karbocyklické
- Piperidony
- Isoindoly
- Lenalidomid
- Carfilzomib
- Pomalidomid
- Talquetamab
Další identifikační čísla studie
- CR108946
- 2020-004502-55 (Číslo EudraCT)
- 64407564MMY1004 (Jiný identifikátor: Janssen Research & Development, LLC)
- 2023-503620-60-00 (Identifikátor registru: EUCT number)
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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