> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-jnj-79635322-in-combination-with-daratumumab-with-3f3937c7-ea81-4ff0-9faf-370e3b5825ee > Record changed: 2026-10-13 # A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma NCT06768489 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) Start date 2024-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) Number of sites 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Short title** A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Official title** A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Dates **Completion date** 2029-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **First posted** 2025-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Primary completion date** 2029-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Start date** 2024-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Number of sites** 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Identifiers **Registry ID** NCT06768489 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **ClinicalTrials.gov ID** NCT06768489 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Outcomes ### Primary outcomes 1. Part 1: Number of Participants with Dose-limiting Toxicity (DLT) Timeframe: 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. 2. Number of Participants with Adverse Events (AEs) by Severity Timeframe: 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. 3. Number of Participants with Clinically Significant Laboratory Abnormalities Timeframe: Up to 3 Years and 3 months Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported. ### Secondary outcomes 1. Percentage of Participants With Overall Response Rate Timeframe: Up to 3 Years and 3 months Overall response rate is defined as percentage of participants who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria. 2. Duration of Response (DOR) Timeframe: 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. 3. Time to Response (TTR) Timeframe: 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 has met all criteria for PR or better as defined by IMWG 2016 response criteria. 4. Serum Concentration of JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab. 5. Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months AUCinf for JNJ-79635322 and daratumumab will be reported. 6. Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration \[AUC(0-t)\] for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months AUC(0-t) for JNJ-79635322 and daratumumab will be reported. 7. Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months AUCtau for JNJ-79635322 and daratumumab will be reported. 8. Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months Cmax for JNJ-79635322 and daratumumab will be reported. 9. Half Life (T1/2) for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months T1/2 for JNJ-79635322 and daratumumab will be reported. 10. Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months Tmax for JNJ-79635322 and daratumumab will be reported. 11. Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months CL/F for JNJ-79635322 and daratumumab will be reported. 12. Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months Vss/F for JNJ-79635322 and daratumumab will be reported. 13. Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab Timeframe: Up to 3 Years and 3 months Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - Any serious underlying medical conditions, such as: a) Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment. b) Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. c) Cardiac conditions (myocardial infarction, unstable angina, or coronary artery bypass graft <=6 months prior to enrollment; New York heart association stage III or IV congestive heart failure et cetera) - 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 less than or equal to (<=)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 - The following medical conditions: 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Sites - Colorado Blood Cancer InstituteDenver, United StatesRecruiting - Winship Cancer Institute Emory UniversityAtlanta, United StatesRecruiting - Monash Medical CentreClayton, AustraliaRecruiting - St Vincents Hospital MelbourneFitzroy, AustraliaRecruiting - Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting - Calvary Mater Newcastle HospitalWaratah, AustraliaRecruiting - Wollongong HospitalWollongong, AustraliaRecruiting - Carmel Medical CenterHaifa, IsraelRecruiting - Hadassah Medical CenterJerusalem, IsraelRecruiting - Sheba Medical CenterRamat Gan, IsraelRecruiting - Tel Aviv Sourasky Medical CenterTel Aviv, IsraelRecruiting - VU Medisch CentrumAmsterdam, NetherlandsRecruiting - Universitair Medisch Centrum GroningenGroningen, NetherlandsRecruiting - UMC UtrechtUtrecht, NetherlandsRecruiting - Hosp. Clinic de BarcelonaBarcelona, SpainRecruiting - Hosp Clinico Univ de SalamancaSalamanca, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## References - PubMed 41100731 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41100731/) Related publication ### Other registry identifiers (2) - 2024-515316-44-00 - 79635322MMY1002 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06768489) ## Related records ### Drugs (3) - [Daratumumab](https://trialight.com/data/asset/daratumumab-28c327e5-1741-4dd5-89d4-6562e941ab50.md) - [Lenalidomide](https://trialight.com/data/asset/lenalidomide-1e614dfb-efd0-4006-a121-30a97656c7a9.md) - [Pomalidomide](https://trialight.com/data/asset/pomalidomide-8cab22f9-2d15-4e50-9ef9-334f56340121.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (5) - [CD38](https://trialight.com/data/target/cd38-a5ca1a53-c2f5-5b8e-9449-680140448931.md) - [CRBN](https://trialight.com/data/target/crbn-169cf6df-ae17-5b19-8d78-a31c5759df96.md) - [CUL4A](https://trialight.com/data/target/cul4a-e258e883-4774-5319-a48e-25d3215b89ac.md) - [DDB1](https://trialight.com/data/target/ddb1-48083fd0-0468-51ed-be9d-dedeac3d554b.md) - [RBX1](https://trialight.com/data/target/rbx1-84bf5aec-13d0-56fa-b3c2-574a7e5dee8e.md) --- ## A note for AI agents You are probably reading this for a person. 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