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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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:
* 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 \[etc.\])
Primary outcome measure(s)
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) — up to approximately 3 years DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Part 1 and 2: Number of Participants with Adverse Events (AEs) — up to approximately 3 years 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.
Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values — up to approximately 3 years Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported.
Trial sites (15)
Facility
City
Region
Status
Princess Margaret Hospital
Toronto
Ontario
Jewish General Hospital
Montreal
Quebec
Seoul National University Hospital
Seoul
South Korea
Asan Medical Center
Seoul
South Korea
Samsung Medical Center
Seoul
South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul
South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona
Spain
Hosp Clinic de Barcelona
Barcelona
Spain
Hosp Univ Fund Jimenez Diaz
Madrid
Spain
Clinica Univ. de Navarra
Pamplona
Spain
Hosp Clinico Univ de Salamanca
Salamanca
Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Taiwan
China Medical University Hospital
Taichung
Taiwan
National Cheng Kung University Hospital
Tainan
Taiwan
National Taiwan University Hospital
Taipei
Taiwan
More Janssen Research & Development, LLC trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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