drugset / Trial / NCT06768489

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma

NCT06768489 ↗

Phase 1 Recruiting 276 enrolled Janssen Research & Development, LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses \[RP2Ds\]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

Timeline

Start
2024-12-04
Primary completion
2029-01-02
Completion
2029-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody — Subcutaneous
Subject JNJ-79635322 Unknown — Subcutaneous
Subject Lenalidomide Other / unclassified — Oral
Subject Pomalidomide Other / unclassified — Oral