Active, not recruiting
Phase 1
A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma
Condition(s) studied
Relapsed or Refractory Multiple Myeloma
Investigational drug(s) / intervention(s)
JNJ-87562761
JNJ-87562761: JNJ-87562761 will be administered.
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).
Eligibility
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 |
|
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