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NCT06768489PHASE1Recruiting

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

Janssen Research & Development, LLC

Start Date

12/4/2024

Completion Date

1/29/2029

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-79635322

DRUG

Daratumumab

DRUG

Pomalidomide

DRUG

Lenalidomide

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Conditions

Multiple Myeloma

Locations

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Winship Cancer Institute Emory University

Atlanta, Georgia 30322

United States

Monash Medical Centre

Clayton, 3168

Australia

St Vincents Hospital Melbourne

Fitzroy, 3065

Australia

Peter MacCallum Cancer Centre

Melbourne, 3000

Australia

Calvary Mater Newcastle Hospital

Waratah, 2298

Australia

Wollongong Hospital

Wollongong, 2500

Australia

Carmel Medical Center

Haifa, 3436212

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

VU Medisch Centrum

Amsterdam, 1081 HV

Netherlands

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ

Netherlands

UMC Utrecht

Utrecht, 3584 CX

Netherlands

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007

Spain