New hope for tough myeloma: first human trial of JNJ-87562761 begins
NCT ID NCT06604715
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This early-phase study tests a new drug, JNJ-87562761, in 17 people with multiple myeloma whose cancer returned or didn't respond to prior treatments. The main goals are to find a safe dose and check for side effects. Participants must have measurable disease and have tried certain prior therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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Dec 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \[etc.\])
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, 05505, South Korea
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China Medical University Hospital
Taichung, 404, Taiwan
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Clinica Univ. de Navarra
Pamplona, 31008, Spain
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Hosp Clinic de Barcelona
Barcelona, 08036, Spain
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Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
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Hosp Univ Fund Jimenez Diaz
Madrid, 28040, Spain
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Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
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Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
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National Cheng Kung University Hospital
Tainan, 70403, Taiwan
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National Taiwan University Hospital
Taipei, 100225, Taiwan
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Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
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Samsung Medical Center
Seoul, 06351, South Korea
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Seoul National University Hospital
Seoul, 03080, South Korea
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The Catholic University of Korea Seoul St Marys Hospital
Seoul, 137 701, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding selinexor to standard therapy extend remission in Hard-to-Treat myeloma?
- Can a new drug combo outsmart Hard-to-Treat myeloma?
- Engineered immune cells take on Hard-to-Treat myeloma
- Home infusion for myeloma drug passes early safety check
- New hope for multiple myeloma: phase 3 trial launches
- New CAR T-Cell therapy targets Hard-to-Treat myeloma