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NCT06768489From ClinicalTrials.govRecruiting

A 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 JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma

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

  • Multiple Myeloma
  • Smoldering Multiple Myeloma
  • Immunoglobulin Light-chain Amyloidosis

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
276
Started
4 December 2024
Main results due
2 January 2029
Study sites
16
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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 (%)

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(16)

  • Colorado Blood Cancer Institute

    Denver, Colorado, United States

    Recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, United States

    Recruiting

  • Monash Medical Centre

    Clayton, Australia

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, Australia

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Australia

    Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, Australia

    Recruiting

  • Wollongong Hospital

    Wollongong, Australia

    Recruiting

  • Carmel Medical Center

    Haifa, Israel

    Recruiting

  • Hadassah Medical Center

    Jerusalem, Israel

    Recruiting

  • Sheba Medical Center

    Ramat Gan, Israel

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

    Recruiting

  • VU Medisch Centrum

    Amsterdam, Netherlands

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, Netherlands

    Recruiting

  • UMC Utrecht

    Utrecht, Netherlands

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, Spain

    Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, Spain

    Recruiting

Showing 16 of 16 sites. 16 of the 16 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06768489. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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