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Résztvevőt keres itt: Egyesült Államok1. fázis

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

A legfontosabb adatok

Ki végzi
Janssen Research & Development, LLC
Hol
Atlanta és Denver (Egyesült Államok)Mind a 2 helyszín megnézéseMég 4 másik országban, 14 helyszínen
Állapot
Toboroz
Fázis
1. fázis
Résztvevők
276 fő, tervezett
Kezdés
2024. dec. 4.
Várható befejezés
2029. jún. 29.
A vizsgálat típusa
Beavatkozással járó, 5 csoport
A vizsgált kezelések
  • JNJ-79635322
  • Daratumumab
  • Pomalidomide
  • Lenalidomide
A regiszteradat frissítve
2026. szeptember 25.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat felnőtteket keres, akiknek myelomája, újonnan felismert AL-amiloidózisa vagy nagy kockázatú lappangó myelomája van. A JNJ-79635322 nevű szert próbálják ki daratumumabbal és más gyógyszerekkel.

Életkor
18 év vagy idősebb
Nem
Minden nem részt vehet
A betegség stádiuma
Újonnan felismert vagy visszatérő/kezelésre nem reagáló myeloma multiplex; újonnan felismert AL-amiloidózis; vagy legfeljebb 5 éve felismert, nagy kockázatú lappangó myeloma. Myeloma esetén mérhető betegség kell.
Korábbi kezelés
A csoporttól függ. Egyes csoportokban 1–3 korábbi kezelési sor kell, benne proteaszóma-gátló és IMiD. Egy másik csoportban legalább 1 korábbi kezelési sor kell, benne proteaszóma-gátló és lenalidomid. Az újonnan felismert csoportok nem kaphattak korábban kezelést myelomára vagy amiloidózisra. Korábbi CD3-irányító kezelés nem megengedett.

A részvétel fő kizáró okai

  • Kezelést igénylő aktív fertőzés, HIV-fertőzés vagy aktív hepatitis B vagy C
  • Őssejt-átültetés az első adag előtti megadott időn belül
  • Korábbi CD3-irányító kezelés
  • Súlyos szív- vagy tüdőprobléma, vagy COPD 50% alatti FEV1-gyel
  • Agyi érkatasztrófa vagy görcsroham az első adag előtti 6 hónapon belül

A regiszter feltételei, szó szerint

Mind a 20 feltétel megnézéseKevesebb

Ki vehet részt

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

Ki nem vehet részt

  • 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
  • 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
  • Prior therapy for AL amyloidosis or multiple myeloma
  • 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 (%)
  • Macroglossia that impairs swallowing difficulty
  • Multiple myeloma, requiring treatment
  • Primary systemic AL (immunoglobulin light chain) amyloidosis

Helyszínek itt: Egyesült Államok

Még 4 másik országban, 14 helyszínen

  • Winship Cancer Institute, Emory UniversityAtlanta, Egyesült ÁllamokRésztvevőt keres
  • Colorado Blood Cancer InstituteDenver, Egyesült ÁllamokRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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).

A vizsgálat 5 csoportja

  • Treatment Regimen A and C: JNJ-79635322+DaratumumabA vizsgált kezelés

    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.

    Kezelés: JNJ-79635322 és Daratumumab

  • Treatment Regimen B: JNJ-79635322+PomalidomideA vizsgált kezelés

    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.

    Kezelés: JNJ-79635322 és Pomalidomide

  • Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide CombinationA vizsgált kezelés

    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.

    Kezelés: JNJ-79635322, Daratumumab és Lenalidomide

  • Treatment Regimen F: JNJ-79635322 + DaratumumabA vizsgált kezelés

    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.

    Kezelés: JNJ-79635322 és Daratumumab

  • Treatment Regimen G: JNJ-79635322 + DaratumumabA vizsgált kezelés

    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.

    Kezelés: JNJ-79635322 és Daratumumab

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
Hivatalos cím
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
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2026. szeptember 25.