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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06768489

Registry updated: 2026-09-25
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Description

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).

Interventions

  • JNJ-79635322 (Drug)
    JNJ-79635322 will be administered subcutaneously.
  • Daratumumab (Drug)
    Daratumumab will be administered subcutaneously.
  • Pomalidomide (Drug)
    Pomalidomide will be administered orally.
  • Lenalidomide (Drug)
    Lenalidomide will be administered orally.

Eligibility criteria

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 (%)

Conditions

Multiple Myeloma Smoldering Multiple Myeloma Immunoglobulin Light-chain Amyloidosis

Locations

  • Colorado Blood Cancer Institute — Denver, Colorado, United States
  • Winship Cancer Institute Emory University — Atlanta, Georgia, United States
  • Monash Medical Centre — Clayton, Australia
  • St Vincents Hospital Melbourne — Fitzroy, Australia
  • Peter MacCallum Cancer Centre — Melbourne, Australia
  • Calvary Mater Newcastle Hospital — Waratah, Australia
  • Wollongong Hospital — Wollongong, Australia
  • Carmel Medical Center — Haifa, Israel
  • Hadassah Medical Center — Jerusalem, Israel
  • Sheba Medical Center — Ramat Gan, Israel
  • Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
  • VU Medisch Centrum — Amsterdam, Netherlands
  • Universitair Medisch Centrum Groningen — Groningen, Netherlands
  • UMC Utrecht — Utrecht, Netherlands
  • Hosp. Clinic de Barcelona — Barcelona, Spain
  • Hosp Clinico Univ de Salamanca — Salamanca, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record