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A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma

24 settembre 2026 aggiornato da: Janssen Research & Development, LLC

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or in Combination With Pomalidomide for Multiple Myeloma

The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

276

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Australia
      • Clayton, Australia, 3168
        • Reclutamento
        • Monash Medical Centre
      • Fitzroy, Australia, 3065
        • Reclutamento
        • St Vincents Hospital Melbourne
      • Melbourne, Australia, 3000
        • Reclutamento
        • Peter MacCallum Cancer Centre
      • Waratah, Australia, 2298
        • Reclutamento
        • Calvary Mater Newcastle Hospital
      • Wollongong, Australia, 2500
        • Reclutamento
        • Wollongong Hospital
  • Israele
      • Haifa, Israele, 3436212
        • Reclutamento
        • Carmel Medical Center
      • Jerusalem, Israele, 9112001
        • Reclutamento
        • Hadassah Medical Center
      • Ramat Gan, Israele, 52621
        • Reclutamento
        • Sheba Medical Center
      • Tel Aviv, Israele, 64239
        • Reclutamento
        • Tel Aviv Sourasky Medical Center
  • Olanda
      • Amsterdam, Olanda, 1081 HV
        • Reclutamento
        • VU Medisch Centrum
      • Groningen, Olanda, 9713 GZ
        • Reclutamento
        • Universitair Medisch Centrum Groningen
      • Utrecht, Olanda, 3584 CX
        • Reclutamento
        • UMC Utrecht
  • Spagna
      • Barcelona, Spagna, 08036
        • Reclutamento
        • Hosp. Clinic de Barcelona
      • Salamanca, Spagna, 37007
        • Reclutamento
        • Hosp Clinico Univ de Salamanca
  • Stati Uniti
    • Colorado
      • Denver, Colorado, Stati Uniti, 80218
        • Reclutamento
        • Colorado Blood Cancer Institute
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Reclutamento
        • Winship Cancer Institute Emory University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria for newly diagnosed multiple myeloma (NDMM) and relapsed or refractory multiple myeloma (R/R MM):

  • Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
  • Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimens A1 and A3: Have been treated with 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an inhibitor, immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM); Treatment regimens A2 and A4: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): Have received greater than or equal to (>=) 1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory OR >=2 prior lines of therapy, including a PI and lenalidomide; Treatment Regimens C, D, and E: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments
  • Have a weight >=40 kilograms
  • Must have an Eastern Cooperative Oncology Group status of 0 or 2
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum monoclonal protein (M-protein) level >= 0.5 gram per deciliter (g/dL); or b) Urine M-protein level >=200 milligram (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. d) For participants without measurable disease in the serum, urine, or involved FLC: presence of 1 or more focus of extramedullary disease which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter (cm) (at its greatest dimension) diameter on whole body positron emission tomography-computed tomography (or whole-body magnetic resonance imaging approved by sponsor), and not previously radiated

Inclusion criteria for newly diagnosed amyloid light chain (ND AL) Amyloidosis

  • Have a histopathological diagnosis of amyloidosis
  • Have an ECOG performance status of 0 to 1

Inclusion criteria for High-risk smoldering multiple myeloma (SMM)

  • Have a diagnosis of SMM (per IMWG criteria) for less than or equal to (<=) 5 years with measurable disease at the time of enrollment as defined in the protocol
  • Have an ECOG performance status of 0 to 1

Exclusion Criteria for NDMM and R/R MM:

  • Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonal antibody (mAb) treatment, or treatment with an investigational drug or an invasive investigational medical device within 21 days or 5 half-lives, whichever is less. b) Gene-modified adoptive cell therapy (example, chimeric antigen receptor [CAR] modified T cells, natural killer cells) within 90 days. c) Prior anti-CD38 directed therapy within 90 days (for treatment regimens A, C, D and E only; within 21 days for treatment regimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14 days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14 days
  • Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months before the first dose of study treatment. b) Received an autologous stem cell transplant <=12 weeks before the first dose of study treatment
  • Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy grade <=3)
  • Prior treatment with CD3-redirecting therapy

Exclusion Criteria for ND AL Amyloidosis

  • Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >=60 percent (%) plasma cells in the bone marrow, or hypercalcemia
  • Macroglossia that impairs swallowing difficulty
  • Prior therapy for AL amyloidosis or multiple myeloma

Exclusion Criteria for High-risk SMM

  • Multiple myeloma, requiring treatment
  • Primary systemic AL (immunoglobulin light chain) amyloidosis

Exclusion criteria for all participants:

  • Any serious underlying medical conditions, such as: Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment; active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment; cardiovascular dysfunction; pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation; human immunodeficiency (HIV) infection; active hepatitis B or C infection; stroke or seizure within 6 months prior to first dose of study treatment
  • Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Treatment Regimen A and C: JNJ-79635322+Daratumumab

Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D[s]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimens A2, A4 and C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Sperimentale: Treatment Regimen B: JNJ-79635322+Pomalidomide

Participants who have received greater than or equal to (>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or >=2 prior lines of therapy, including a PI and lenalidomide will receive JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Pomalidomide

Pomalidomide will be administered orally.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Sperimentale: Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination

Participants with NDMM will receive JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Lenalidomide

Lenalidomide will be administered orally.

Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Sperimentale: Treatment Regimen F: JNJ-79635322 + Daratumumab

Participants with newly diagnosed amyloid light chain (ND AL) amyloidosis will receive JNJ-79635322 in treatment regimen F along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Sperimentale: Treatment Regimen G: JNJ-79635322 + Daratumumab

Participants with high-risk smoldering multiple myeloma (SMM) will receive JNJ-79635322 in treatment regimen G along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Lasso di tempo: Up to 28 days

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Up to 28 days
Number of Participants with Adverse Events (AEs) by Severity
Lasso di tempo: Up to 3 Years and 3 months

An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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 adverse event.
Up to 3 Years and 3 months
Number of Participants with Clinically Significant Laboratory Abnormalities
Lasso di tempo: Up to 3 Years and 3 months

Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
Up to 3 Years and 3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Overall Response Rate
Lasso di tempo: Up to 3 Years and 3 months

Overall response rate is defined as percentage of participants with newly diagnosed multiple myeloma (NDMM), relapsed or refractory multiple myeloma (R/R MM), or high-risk smoldering multiple myeloma (SMM) who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate
Lasso di tempo: Up to 3 Years and 3 months

VGPR or better response rate is defined as the percentage of participants with NDMM, R/R MM, or high-risk SMM who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With CR or Better Response Rate
Lasso di tempo: Up to 3 Years and 3 months

CR or better response rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With sCR or Better Response Rate
Lasso di tempo: Up to 3 Years and 3 months

sCR rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve an sCR according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Duration of Response (DOR)
Lasso di tempo: Up to 3 Years and 3 months

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first in participants with NDMM, R/R MM, or high-risk SMM.
Up to 3 Years and 3 months
Time to Response (TTR)
Lasso di tempo: Up to 3 Years and 3 months

TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participants with NDMM, R/R MM, or high-risk SMM has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Up to 3 Years and 3 months
Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria
Lasso di tempo: Up to 3 Years and 3 months

Hematologic response is defined as percentage of participants with newly diagnosed amyloid light chain (ND AL) amyloidosis who achieve complete response, very good partial response, partial response, no response and progression as defined by International amyloidosis consensus criteria present in the protocol will be reported.
Up to 3 Years and 3 months
DOR as Defined by International Amyloidosis Consensus Criteria
Lasso di tempo: Up to 3 Years and 3 months

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per International amyloidosis consensus criteria, or death due to progression, whichever occurs first in participants with ND AL amyloidosis.
Up to 3 Years and 3 months
TTR as Defined by International Amyloidosis Consensus Criteria
Lasso di tempo: Up to 3 Years and 3 months

TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant with ND AL amyloidosis has met all criteria for PR or better as defined by International amyloidosis consensus criteria.
Up to 3 Years and 3 months
Serum Concentration of JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

AUCinf for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

AUC(0-t) for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

AUCtau for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

Cmax for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Half Life (T1/2) for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

T1/2 for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

Tmax for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

CL/F for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

Vss/F for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab
Lasso di tempo: Up to 3 Years and 3 months

Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 dicembre 2024

Completamento primario (Stimato)

2 gennaio 2029

Completamento dello studio (Stimato)

29 giugno 2029

Date di iscrizione allo studio

Primo inviato

23 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

9 gennaio 2025

Primo Inserito (Effettivo)

10 gennaio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 79635322MMY1002
  • 2024-515316-44-00 (Identificatore di registro: EUCT number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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