A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria Have relapsed or refractory disease and have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM) 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 of plasmacytomas (>=2 centimeter [cm]) Exclusion Criteria: 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 Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days) 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 Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3) The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, etc)
Sites / Locations
- UZ AntwerpenRecruiting
- UZ GentRecruiting
- CHU de LiègeRecruiting
- CHU NantesRecruiting
- CHU Lyon SudRecruiting
- Chu Rennes - Hopital PontchaillouRecruiting
- Institut Claudius RegaudRecruiting
- VUMC AmsterdamRecruiting
- Hosp. Univ. Germans Trias I PujolRecruiting
- Hosp. Clinic I Provincial de BarcelonaRecruiting
- Hosp. Univ. Fund. Jimenez DiazRecruiting
- Clinica Univ. de NavarraRecruiting
- Hosp. Clinico Univ. de SalamancaRecruiting
- University College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1: Dose Escalation
Part 2: Dose Expansion
Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.