ClinicaliQ Trial Snapshot
- A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis — Recruiting • Phase I • Cardiology / Cardiovascular • NCT05652335.
- What is being tested: JNJ-79635322, a novel investigational agent, is undergoing dose escalation and safety characterization in patients with relapsed or refractory multiple myeloma or previously treated AL amyloidosis to establish the recommended phase 2 dose and schedule.
- Patient eligibility overview: The trial enrolls adults with multiple myeloma who have relapsed or become refractory to prior treatment, or patients with AL amyloidosis who have received previous therapy, representing heavily pre-treated populations with limited treatment options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
Eligibility Snapshot
- : For participants with relapsed or refractory multiple myeloma: * Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy * Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 * Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.