Testing JNJ-87562761 for patients with relapsed or refractory multiple myeloma
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-87562761 in Relapsed/Refractory Multiple Myeloma
This study is testing a new medication called JNJ-87562761 to see how much of it is safe and effective for people with multiple myeloma that hasn’t responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 15 sites (Toronto, Ontario and 14 other locations) |
| Trial ID | NCT06604715 on ClinicalTrials.gov |
What this trial studies
This study aims to find the recommended phase 2 doses of JNJ-87562761 through a two-part approach. In Part 1, the study will escalate doses to determine the optimal amount, while Part 2 will focus on assessing the safety and tolerability of this dose in participants with multiple myeloma that has either relapsed or is refractory to previous treatments. Participants must have measurable disease and a history of specific prior therapies. The study is designed to provide insights into the efficacy of this new treatment option.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have previously received specific therapies.
Not a fit: Patients who have not been previously treated for multiple myeloma or those with an ECOG performance status greater than 1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar approaches in treating multiple myeloma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \[etc.\])
Where this trial is running
Toronto, Ontario and 14 other locations
- Princess Margaret Hospital — Toronto, Ontario, Canada (Recruiting)
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- The Catholic University of Korea Seoul St Marys Hospital — Seoul, South Korea (Recruiting)
- Hosp. Univ. Germans Trias I Pujol — Badalona, Spain (Recruiting)
- Hosp Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain (Recruiting)
- Clinica Univ. de Navarra — Pamplona, Spain (Recruiting)
- Hosp Clinico Univ de Salamanca — Salamanca, Spain (Recruiting)
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.