[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunoglobulin-light-chain-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunoglobulin-light-chain-amyloidosis":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100575146","phase-1-a-study-of-jnj-79635322-in-combination-with-daratumumab-with-or-without-lenalidomide-or-in-combination-with-pomalidomide-for-multiple-myeloma-100575146",false,"NCT06768489","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 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","Inclusion Criteria for newly diagnosed multiple myeloma (NDMM) and relapsed or refractory multiple myeloma (R\u002FR MM):\n\n* Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria\n* 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\n* Have a weight \\>=40 kilograms\n* Must have an Eastern Cooperative Oncology Group status of 0 or 2\n* 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\u002FdL); or b) Urine M-protein level \\>=200 milligram (mg)\u002F24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \\>= 10 mg\u002FdL 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\n\nInclusion criteria for newly diagnosed amyloid light chain (ND AL) Amyloidosis\n\n* Have a histopathological diagnosis of amyloidosis\n* Have an ECOG performance status of 0 to 1\n\nInclusion criteria for High-risk smoldering multiple myeloma (SMM)\n\n* Have a diagnosis of SMM (per IMWG criteria) for less than or equal to (\\\u003C=) 5 years with measurable disease at the time of enrollment as defined in the protocol\n* Have an ECOG performance status of 0 to 1\n\nExclusion Criteria for NDMM and R\u002FR MM:\n\n* 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\n* 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 \\\u003C=12 weeks before the first dose of study treatment\n* Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade \\\u003C=1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy grade \\\u003C=3)\n* Prior treatment with CD3-redirecting therapy\n\nExclusion Criteria for ND AL Amyloidosis\n\n* 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\n* Macroglossia that impairs swallowing difficulty\n* Prior therapy for AL amyloidosis or multiple myeloma\n\nExclusion Criteria for High-risk SMM\n\n* Multiple myeloma, requiring treatment\n* Primary systemic AL (immunoglobulin light chain) amyloidosis\n\nExclusion criteria for all participants:\n\n* 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\n* Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (\\\u003C) 50 percent (%)","ALL","18 Years",{"count":19,"type":20},276,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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).",[26,27,28],"Multiple Myeloma","Smoldering Multiple Myeloma","Immunoglobulin Light-chain Amyloidosis","RECRUITING","2026-09-24",{"date":32,"type":33},"2026-09-25","ACTUAL",{"date":35,"type":33},"2024-12-04",{"date":37,"type":20},"2029-06-29",{"name":39,"class":40},"Janssen Research & Development, LLC","INDUSTRY",16,"Immunoglobulin Light-Chain Amyloidosis"]