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Active, not recruitingNCT06604715Updated Sep 25, 2026

A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1 interventional study of JNJ-87562761 in Relapsed or Refractory Multiple Myeloma, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 15 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease has come back after treatment (relapsed) or hasn't responded to treatment (refractory).

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Conditions studied

  • Relapsed or Refractory Multiple Myeloma
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 17 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Relapsed, refractory multiple myeloma with measurable disease defined as: (a) Serum monoclonal paraprotein (M-protein) level greater than (>)0.5 grams per deciliter (g/dL); or (b) Urine M-protein level >200 milligrams per 24 hours (mg/24 hours); or (c) Light chain multiple myeloma: serum immunoglobulin free light chain (FLC) >10 milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa-lambda FLC ratio
  • Must have had prior therapy including a proteasome inhibitor, immunomodulatory agent and anti-CD38 therapy
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Have an estimated glomerular filtration rate (eGFR), of > 30 millilitres (mL)/min/1.73 meter square (m\^2) computed per 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation
  • While on study treatment and for 6 months after the last dose of study treatment, a participant must: (a) Not breastfeed or be pregnant; (b) Not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; (c) Wear an external condom

Exclusion criteria

Exclusion Criteria:

  • Active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or immunoglobulin light chain amyloidosis
  • Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to less than or equal to (\<=) Grade 1 (except alopecia, tissue post-RT fibrosis, or Grade \< 3 peripheral neuropathy)
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to (>=) 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Prior antitumor therapy in the specified time frame prior to the first dose of study treatment: (Targeted therapy, epigenetic therapy, monoclonal antibody treatment, or treatment with an investigational drug or an invasive investigational medical device or conventional chemotherapy within 21 days, gene-modified adoptive cell therapy or treatment with anti-CD38 directed therapies within 3 months, proteasome inhibitor [PI] therapy or radiotherapy within 14 days, or immunomodulatory drug (IMiD) agent therapy within 7 days)
  • Following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection (participants with a detectable viral load or low CD4 count), active hepatitis B or C infection, active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment, serious uncontrolled ongoing viral or bacterial or systemic fungal infection, cardiac conditions (myocardial infarction \<=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera [etc.])
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    JNJ-87562761

    Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1.

    Drug: JNJ-87562761

Interventions

  • DrugJNJ-87562761

    JNJ-87562761 will be administered.

06

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

    DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

    Time frame: up to approximately 3 years

  2. Part 1 and 2: Number of Participants with Adverse Events (AEs)

    Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Time frame: up to approximately 3 years

  3. Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values

    Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported.

    Time frame: up to approximately 3 years

Secondary outcomes

  1. Serum Concentration of JNJ-87562761

    Serum samples will be analyzed to determine concentrations of JNJ-87562761.

    Time frame: up to approximately 3 years

  2. Pharmacokinetic (PK) Parameters of JNJ-87562761

    PK parameters for JNJ-87562761 will be evaluated.

    Time frame: up to approximately 3 years

  3. Number of Participants with Presence of Anti-JNJ-87562761 Antibodies

    Number of participants with presence of anti-JNJ-87562761 antibodies will be reported.

    Time frame: up to approximately 3 years

  4. Percentage of Participants with Response

    Overall response is defined as a best response of partial response (PR) or better as assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.

    Time frame: up to approximately 3 years

  5. Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better

    VGPR or better response is defined as the percentage of participants who achieve a best response of VGPR or better as assessed by IMWG 2016 response criteria.

    Time frame: up to approximately 3 years

  6. Percentage of Participants Who Achieve Complete Response (CR) or Better

    CR or better response is defined as percentage of participants who achieve a best response of CR or better as assessed by IMWG 2016 response criteria.

    Time frame: up to approximately 3 years

  7. Percentage of Participants Who Achieve Stringent Complete Response (sCR)

    sCR is defined as the percentage of participants who achieve a best response of sCR as assessed by IMWG 2016 response criteria.

    Time frame: up to approximately 3 years

  8. Duration of Response (DOR)

    DOR is defined for participants who achieve a response of PR or better as the time from the first efficacy evaluation at which the participant met all criteria for a response of PR or better to the time of first documented evidence of progressive disease or death, assessed by IMWG 2016 response criteria.

    Time frame: up to approximately 3 years

  9. Time to Response (TTR)

    TTR is defined for participants who achieve a response of PR or better as the time from the first dose of study drug to the time of the first efficacy evaluation at which the participant met all criteria for a response of PR or better, assessed by IMWG 2016 response criteria.

    Time frame: up to approximately 3 years

07

Study locations

15 sites
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
  • Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
  • Seoul National University Hospital
    Seoul, 03080, South Korea
  • Asan Medical Center
    Seoul, 05505, South Korea
  • Samsung Medical Center
    Seoul, 06351, South Korea
  • The Catholic University of Korea Seoul St Marys Hospital
    Seoul, 137 701, South Korea
  • Hosp. Univ. Germans Trias I Pujol
    Badalona, 08916, Spain
  • Hosp Clinic de Barcelona
    Barcelona, 08036, Spain
  • Hosp Univ Fund Jimenez Diaz
    Madrid, 28040, Spain
  • Clinica Univ. de Navarra
    Pamplona, 31008, Spain
  • Hosp Clinico Univ de Salamanca
    Salamanca, 37007, Spain
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung City, 833, Taiwan
  • China Medical University Hospital
    Taichung, 404, Taiwan
  • National Cheng Kung University Hospital
    Tainan, 70403, Taiwan
  • National Taiwan University Hospital
    Taipei, 100225, Taiwan
08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06604715
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Dec 19, 2024
Primary completion
Nov 3, 2027 (estimated)
Completion
Nov 15, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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