Clinical Trial Details
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
Overview
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).
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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 (%)
