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

Last updated: March 27, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Platelet Disorders

Cancer

Treatment

JNJ-79635322

Daratumumab

Pomalidomide

Clinical Study ID

NCT06768489
79635322MMY1002
2024-515316-44-00
79635322MMY1002
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have documented initial diagnosis of multiple myeloma according to IMWG diagnosticcriteria

  • Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimen A1: Have been treated with 1 to 3 priorlines 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 relatedplasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): Have received greater than or equal to (>=) 1 priorline 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 multiplemyeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormalserum Ig kappa lambda FLC ratio. d) For participants without measurable disease inthe serum, urine, or involved FLC: presence of 1 or more focus of extramedullarydisease which meets the following criteria: extramedullary plasmacytoma notcontiguous with a bone lesion, at least 1 lesion >=2 centimeter (cm) (at itsgreatest dimension) diameter on whole body positron emission tomography-computedtomography (or whole-body magnetic resonance imaging approved by sponsor), and notpreviously radiated

Exclusion

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 systemicimmunosuppressive therapy within 6 months before start of study treatment. c)Cardiac conditions (myocardial infarction, unstable angina, or coronary arterybypass graft <=6 months prior to enrollment; New york heart association stage III orIV congestive heart failure etcetera)

  • Prior antitumor therapy as follows, in the specified time frame prior to the firstdose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonalantibody (mAb) treatment, or treatment with an investigational drug or an invasiveinvestigational 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 directedtherapy within 90 days (for treatment regimen A only; within 21 days for treatmentregimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14days

  • Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months beforethe first dose of study treatment. b) Received an autologous stem cell transplantless than or equal to (<=)12 weeks before the first dose of study treatment

  • Nonhematologic toxicity from prior anticancer therapy that has not resolved tobaseline 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 oxygenuse to maintain adequate oxygenation, human immunodeficiency (HIV) infection, activehepatitis B or C infection, stroke or seizure within 6 months prior to first dose ofstudy treatment

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: JNJ-79635322
Phase: 1
Study Start date:
December 04, 2024
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • Monash Medical Centre

    Clayton, 3168
    Australia

    Active - Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, 3065
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, 2298
    Australia

    Active - Recruiting

  • Carmel Medical Center

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv Yafo, 64239
    Israel

    Active - Recruiting

  • VU Medisch Centrum

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.