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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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 240 → 276 participants Completion pushed from Jan 29, 2029 to Jun 29, 2029 · Trial arms changed: 3 → 5 Show 2 more changesShow less
    • Completion pushed from Jan 29, 2029 to Jun 29, 2029
    • Trial arms changed: 3 → 5
  2. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Completion date: Jan 29, 2029 to Jun 29, 2029 · Eligibility criteria expanded, about 163 words · Secondary endpoints: 13 to 19 · 3 more Show 6 more changesShow less
    • Completion date: Jan 29, 2029 to Jun 29, 2029
    • Eligibility criteria expanded, about 163 words
    • Secondary endpoints: 13 to 19
    • Publications: details revised at 1 of 1 entry
    • Study title expanded, about 13 words
    • Study arms: 3 to 5
  3. Study sites: 14 to 16 Completion date: Jan 2, 2029 to Jan 29, 2029v19 Show 1 more changeShow less
    • Completion date: Jan 2, 2029 to Jan 29, 2029
  4. Primary completion pushed from Nov 19, 2027 to Jan 2, 2029 Enrollment increased: 140 → 240 participantsv18 Show 1 more changeShow less
    • Enrollment increased: 140 → 240 participants
  5. Completion pushed from Nov 23, 2028 to Jan 2, 2029 Eligibility criteria expanded, about 8 wordsv17 Show 1 more changeShow less
    • Eligibility criteria expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

Show 15 earlier versionsHide 15 earlier versions
  1. 3 versions Re-verified since Mar 12, 2026, no change to tracked fieldsv14-v16
  2. Completion date: Jun 20, 2028 to Nov 23, 2028v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary completion date: Mar 31, 2028 to Nov 19, 2027 Completion date: Mar 31, 2028 to Jun 20, 2028v11 Show 1 more changeShow less
    • Completion date: Mar 31, 2028 to Jun 20, 2028
  5. 3 versions Re-verified since Jul 17, 2025, no change to tracked fieldsv8-v10
  6. Enrollment target: 100 to 140 Study sites: 13 to 14 · Interventions: Daratumumab (Drug), JNJ-79635322 (Drug), Pomalidomide (Drug) to Daratumumab (Drug), JNJ-79635322 (Drug), Lenalidomide (Drug), Pomalidomide (Drug) · Eligibility criteria expanded, about 21 words · 2 morev7 Show 5 more changesShow less
    • Study sites: 13 to 14
    • Interventions: Daratumumab (Drug), JNJ-79635322 (Drug), Pomalidomide (Drug) to Daratumumab (Drug), JNJ-79635322 (Drug), Lenalidomide (Drug), Pomalidomide (Drug)
    • Eligibility criteria expanded, about 21 words
    • Study title expanded, about 7 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  7. 2 versions Re-verified since Mar 27, 2025, no change to tracked fieldsv5-v6
  8. Study sites: 10 to 13v4
  9. Re-verified, no change to tracked fieldsv3
  10. Study sites: 7 to 10v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Johnson & Johnson
289 trials monitored
See 17 trials at risk
Multiple Myeloma
1,231 trials monitored
See 77 trials at risk
Amyloidosis
301 trials monitored
See 19 trials at risk
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).
Trial Details
NCT Number NCT06768489
Lead Sponsor Janssen Research & Development, LLC
Conditions Multiple Myeloma, Smoldering Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov