A Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma

Last Updated March 26, 2025

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79635322MMY1002

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1

1
Sites
13 Sites
Status

Recruiting

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 either daratumumab or pomalidomide; and for Part 2 (Dose Expansion) is to further define the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

CONDITIONS

Multiple Myeloma

ELIGIBILITY

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 regimen A1: 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 regimen A2: 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
* 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 etcetera)
* 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 regimen A 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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

Australia, Israel, Netherlands, Spain

Country (4)	City or Province (13)	Status
Australia	Fitzroy St Vincents Hospital Melbourne	RECRUITING
Australia	Melbourne Peter MacCallum Cancer Centre	RECRUITING
Australia	Waratah Calvary Mater Newcastle Hospital	RECRUITING
Israel	Haifa Carmel Medical Center	RECRUITING
Israel	Jerusalem Hadassah Medical Center	RECRUITING
Israel	Ramat Gan Sheba Medical Center	RECRUITING
Israel	Tel Aviv Yafo Tel Aviv Sourasky Medical Center	RECRUITING
Netherlands	Utrecht UMC Utrecht	RECRUITING
Spain	Barcelona Hosp. Clinic de Barcelona	RECRUITING
Spain	Salamanca Hosp Clinico Univ de Salamanca	RECRUITING
Australia	Clayton Monash Medical Centre	RECRUITING
Netherlands	Amsterdam VU Medisch Centrum	RECRUITING
Netherlands	Groningen Universitair Medisch Centrum Groningen	RECRUITING

Geo Locations

-37.79839, 144.97833

-37.814, 144.96332

-32.90667, 151.72647

32.81841, 34.9885

31.76904, 35.21633

32.08227, 34.81065

32.08088, 34.78057

52.09083, 5.12222

41.38879, 2.15899

40.96882, -5.66388

-37.91667, 145.11667

52.37403, 4.88969

53.21917, 6.56667

Indicates 50+ sites in this region: click to zoom in.

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Corresponds to individual site.

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