Une étude du JNJ-87562761 chez des participants atteints de myélome multiple en rechute ou réfractaire
Une étude de phase 1, première chez l'homme, ouverte, sur l'augmentation de la dose du JNJ-87562761 dans le myélome multiple récidivant/réfractaire
The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease has come back after treatment (relapsed) or hasn't responded to treatment (refractory).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 05505
- Asan Medical Center
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Seoul, Corée du Sud, 06351
- Samsung Medical Center
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Seoul, Corée du Sud, 137 701
- The Catholic University of Korea Seoul St Marys Hospital
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Badalona, Espagne, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Espagne, 08036
- Hosp Clinic de Barcelona
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Madrid, Espagne, 28040
- Hosp Univ Fund Jimenez Diaz
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Pamplona, Espagne, 31008
- Clinica Univ. de Navarra
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Salamanca, Espagne, 37007
- Hosp Clinico Univ de Salamanca
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Kaohsiung City, Taïwan, 833
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taïwan, 404
- China Medical University Hospital
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Tainan, Taïwan, 70403
- National Cheng Kung University Hospital
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Taipei, Taïwan, 100225
- National Taiwan University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Relapsed, refractory multiple myeloma with measurable disease defined as: (a) Serum monoclonal paraprotein (M-protein) level greater than (>)0.5 grams per deciliter (g/dL); or (b) Urine M-protein level >200 milligrams per 24 hours (mg/24 hours); or (c) Light chain multiple myeloma: serum immunoglobulin free light chain (FLC) >10 milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa-lambda FLC ratio
- Must have had prior therapy including a proteasome inhibitor, immunomodulatory agent and anti-CD38 therapy
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
- Have an estimated glomerular filtration rate (eGFR), of > 30 millilitres (mL)/min/1.73 meter square (m^2) computed per 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation
- While on study treatment and for 6 months after the last dose of study treatment, a participant must: (a) Not breastfeed or be pregnant; (b) Not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; (c) Wear an external condom
Exclusion Criteria:
- Active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or immunoglobulin light chain amyloidosis
- Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to less than or equal to (<=) Grade 1 (except alopecia, tissue post-RT fibrosis, or Grade < 3 peripheral neuropathy)
- Received a cumulative dose of corticosteroids equivalent to greater than or equal to (>=) 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy in the specified time frame prior to the first dose of study treatment: (Targeted therapy, epigenetic therapy, monoclonal antibody treatment, or treatment with an investigational drug or an invasive investigational medical device or conventional chemotherapy within 21 days, gene-modified adoptive cell therapy or treatment with anti-CD38 directed therapies within 3 months, proteasome inhibitor [PI] therapy or radiotherapy within 14 days, or immunomodulatory drug (IMiD) agent therapy within 7 days)
- Following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection (participants with a detectable viral load or low CD4 count), active hepatitis B or C infection, active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment, serious uncontrolled ongoing viral or bacterial or systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera [etc.])
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: JNJ-87562761
Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1. |
JNJ-87562761 will be administered. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Délai: up to approximately 3 years
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DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. |
up to approximately 3 years
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Part 1 and 2: Number of Participants with Adverse Events (AEs)
Délai: up to approximately 3 years
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Number of participants with AEs will be reported. 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 approximately 3 years
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Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values
Délai: up to approximately 3 years
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Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported. |
up to approximately 3 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum Concentration of JNJ-87562761
Délai: up to approximately 3 years
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Serum samples will be analyzed to determine concentrations of JNJ-87562761. |
up to approximately 3 years
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Pharmacokinetic (PK) Parameters of JNJ-87562761
Délai: up to approximately 3 years
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PK parameters for JNJ-87562761 will be evaluated. |
up to approximately 3 years
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Number of Participants with Presence of Anti-JNJ-87562761 Antibodies
Délai: up to approximately 3 years
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Number of participants with presence of anti-JNJ-87562761 antibodies will be reported. |
up to approximately 3 years
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Percentage of Participants with Response
Délai: up to approximately 3 years
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Overall response is defined as a best response of partial response (PR) or better as assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria. |
up to approximately 3 years
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Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better
Délai: up to approximately 3 years
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VGPR or better response is defined as the percentage of participants who achieve a best response of VGPR or better as assessed by IMWG 2016 response criteria. |
up to approximately 3 years
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Percentage of Participants Who Achieve Complete Response (CR) or Better
Délai: up to approximately 3 years
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CR or better response is defined as percentage of participants who achieve a best response of CR or better as assessed by IMWG 2016 response criteria. |
up to approximately 3 years
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Percentage of Participants Who Achieve Stringent Complete Response (sCR)
Délai: up to approximately 3 years
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sCR is defined as the percentage of participants who achieve a best response of sCR as assessed by IMWG 2016 response criteria. |
up to approximately 3 years
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Duration of Response (DOR)
Délai: up to approximately 3 years
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DOR is defined for participants who achieve a response of PR or better as the time from the first efficacy evaluation at which the participant met all criteria for a response of PR or better to the time of first documented evidence of progressive disease or death, assessed by IMWG 2016 response criteria. |
up to approximately 3 years
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Time to Response (TTR)
Délai: up to approximately 3 years
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TTR is defined for participants who achieve a response of PR or better as the time from the first dose of study drug to the time of the first efficacy evaluation at which the participant met all criteria for a response of PR or better, assessed by IMWG 2016 response criteria. |
up to approximately 3 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Tumeurs
- Attributs de la maladie
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies hématologiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Tumeurs, plasmocyte
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Troubles hémorragiques
- Conditions pathologiques, signes et symptômes
- Maladies hémiques et lymphatiques
- Récurrence
- Myélome multiple
Autres numéros d'identification d'étude
- 87562761MMY1001
- 87562761MMY1001 (Autre identifiant: Janssen Research & Development, LLC)
- 2024-513439-25-00 (Identificateur de registre: EUCT number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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
Informations sur les médicaments et les dispositifs, documents d'étude
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