Badanie talquetamabu z innymi terapiami przeciwnowotworowymi u uczestników ze szpiczakiem mnogim (MonumenTAL-2)
Wieloramienne badanie fazy 1b talquetamabu z innymi terapiami przeciwnowotworowymi u uczestników ze szpiczakiem mnogim
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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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, Belgia, 1200
- Cliniques Universitaires St-Luc
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Edegem, Belgia, 2650
- UZA
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Ghent, Belgia, 9000
- UZ Gent
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Leuven, Belgia, 3000
- UZ Leuven
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Nantes, Francja, 44093
- CHU Nantes
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Pessac, Francja, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes, Francja, 35000
- Chu Rennes Hopital Pontchaillou
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Toulouse, Francja, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Groningen, Holandia, 9713 GZ
- UMCG
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Maastricht, Holandia, 6229 HX
- Maastricht University Medical Centre
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Utrecht, Holandia, 3584 CX
- UMCU
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Stany Zjednoczone, 94143
- University of California San Francisco
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Indiana University
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Stany Zjednoczone, 10065
- Weill Cornell Medical College
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New York, New York, Stany Zjednoczone, 10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37203
- Tennessee Oncology
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Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College Of Wisconsin
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London, Zjednoczone Królestwo, W1T 7HA
- University College Hospital London
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Manchester, Zjednoczone Królestwo, M20 4BX
- The Christie Nhs Foundation Trust
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Oxford, Zjednoczone Królestwo, OX3 7LE
- Churchill Hospital
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Surrey, Zjednoczone Królestwo, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
Carfilzomib will be administered as an IV infusion. |
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Eksperymentalny: 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.
Inne nazwy:
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
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Eksperymentalny: 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.
Inne nazwy:
Lenalidomide will be self-administered orally. |
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Eksperymentalny: 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.
Inne nazwy:
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
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Eksperymentalny: 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.
Inne nazwy:
Pomalidomide will be self-administered orally. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Overall Response Rate (ORR)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby naczyniowe
- Choroby układu krążenia
- Nowotwory
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Choroby hematologiczne
- Zaburzenia limfoproliferacyjne
- Zaburzenia immunoproliferacyjne
- Nowotwory, komórki plazmatyczne
- Zaburzenia hemostatyczne
- Paraproteinemie
- Zaburzenia białek krwi
- Zaburzenia krwotoczne
- Choroby hemowe i limfatyczne
- Szpiczak mnogi
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Związki heterocykliczne, 2-ring
- Związki heterocykliczne, sterowanie stopieniem
- Kwasy karboksylowe
- Piperydyny
- Ftalimidy
- Kwasy ftaliczne
- Kwasy, karbocykliczne
- Piperidones
- Izoindoles
- Lenalidomid
- Carfilzomib
- pomalidomid
- Talquetamab
Inne numery identyfikacyjne badania
- CR108946
- 2020-004502-55 (Numer EudraCT)
- 64407564MMY1004 (Inny identyfikator: Janssen Research & Development, LLC)
- 2023-503620-60-00 (Identyfikator rejestru: EUCT number)
- 2023 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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