En undersøgelse af Talquetamab med andre anticancerterapier hos deltagere med myelomatose (MonumenTAL-2)
En multi-arm fase 1b undersøgelse af Talquetamab med andre anticancerterapier hos deltagere med myelomatose
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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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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London, Det Forenede Kongerige, W1T 7HA
- University College Hospital London
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Manchester, Det Forenede Kongerige, M20 4BX
- The Christie Nhs Foundation Trust
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Oxford, Det Forenede Kongerige, OX3 7LE
- Churchill Hospital
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Surrey, Det Forenede Kongerige, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Forenede Stater, 94143
- University of California San Francisco
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Forenede Stater, 10065
- Weill Cornell Medical College
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New York, New York, Forenede Stater, 10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College Of Wisconsin
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Nantes, Frankrig, 44093
- CHU Nantes
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Pessac, Frankrig, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes, Frankrig, 35000
- Chu Rennes Hopital Pontchaillou
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Toulouse, Frankrig, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Groningen, Holland, 9713 GZ
- UMCG
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Maastricht, Holland, 6229 HX
- Maastricht University Medical Centre
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Utrecht, Holland, 3584 CX
- UMCU
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
Carfilzomib will be administered as an IV infusion. |
|
Eksperimentel: 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.
Andre navne:
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
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Eksperimentel: 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.
Andre navne:
Lenalidomide will be self-administered orally. |
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Eksperimentel: 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.
Andre navne:
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
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Eksperimentel: 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.
Andre navne:
Pomalidomide will be self-administered orally. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Response Rate (ORR)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, Plasmacelle
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Hæmoragiske lidelser
- Hemiske og lymfatiske sygdomme
- Myelomatose
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Carboxylsyrer
- Piperidiner
- Phthalimider
- Phthalinsyrer
- Syrer, carbocykliske
- Piperidones
- Isoindoler
- Lenalidomid
- carfilzomib
- Pomalidomid
- Talquetamab
Andre undersøgelses-id-numre
- CR108946
- 2020-004502-55 (EudraCT nummer)
- 64407564MMY1004 (Anden identifikator: Janssen Research & Development, LLC)
- 2023-503620-60-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
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