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Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

Study acronym: QUINTESSENTIAL
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 9 words Secondary endpoints: details revised at 1 of 17 entries · Site details revised at 4 of 52 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 17 entries
    • Site details revised at 4 of 52 sites
  2. Minor Primary completion date changed from estimate of Jun 30, 2027 to Jul 31, 2026 Site details revised at 8 of 52 sitesv27 Show 1 more changeShow less
    • Site details revised at 8 of 52 sites
  3. Minor Study sites revised (52)v26 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study sites revised (52)v25 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites revised (52)v24 See this version in full on ClinicalTrials.gov ↗
Show 22 earlier versionsHide 22 earlier versions
  1. Notable Primary endpoint revised Enrollment target: 175 to 230 · Interventions: Arlocabtagene Autoleucel (BMS-986393) (Biological) to Arlocabtagene Autoleucel (Biological) · Eligibility criteria expanded, about 20 words · 2 morev23 Show 5 more changesShow less
    • Enrollment target: 175 to 230
    • Interventions: Arlocabtagene Autoleucel (BMS-986393) (Biological) to Arlocabtagene Autoleucel (Biological)
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 18 to 17
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study sites revised (52)v22 See this version in full on ClinicalTrials.gov ↗
  3. Minor Study sites revised (52)v21 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study sites revised (52)v20 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites revised (52)v19 See this version in full on ClinicalTrials.gov ↗
  6. Minor Study sites revised (52)v18 See this version in full on ClinicalTrials.gov ↗
  7. Minor Study sites: 48 to 52v17
  8. Notable Primary endpoint revised Enrollment target: 150 to 175 · Interventions: BMS-986393 (Biological) to Arlocabtagene Autoleucel (BMS-986393) (Biological) · Eligibility criteria shortened, about 7 words · 3 morev16 Show 6 more changesShow less
    • Enrollment target: 150 to 175
    • Interventions: BMS-986393 (Biological) to Arlocabtagene Autoleucel (BMS-986393) (Biological)
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 23 to 18
    • Study sites revised (48)
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Minor Study sites: 47 to 48v15
  10. Notable Primary completion date: Oct 2, 2026 to Jun 30, 2027 Completion date: Jun 4, 2030 to Jun 30, 2032 · Study sites revised (47)v14 Show 2 more changesShow less
    • Completion date: Jun 4, 2030 to Jun 30, 2032
    • Study sites revised (47)

    See this version in full on ClinicalTrials.gov ↗

  11. Minor Secondary endpoints revised (23) Study sites revised (47) · Eligibility criteria shortened, about 3 wordsv13 Show 2 more changesShow less
    • Study sites revised (47)
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  12. Minor Study sites revised (47)v12 See this version in full on ClinicalTrials.gov ↗
  13. Minor Study sites: 43 to 47v11
  14. Minor Study sites: 42 to 43v10
  15. Minor Study sites revised (42)v9 See this version in full on ClinicalTrials.gov ↗
  16. Minor Study sites revised (42)v8 See this version in full on ClinicalTrials.gov ↗
  17. Minor Study sites: 37 to 42v7
  18. Minor Study sites: 36 to 37v6
  19. Minor Study sites revised (36)v5 See this version in full on ClinicalTrials.gov ↗
  20. Minor Study sites revised (36)v4 See this version in full on ClinicalTrials.gov ↗
  21. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 25 to 36 · Start date changed from estimate of Apr 15, 2024 to Mar 21, 2024 · Eligibility criteria revised · 1 morev3 Show 4 more changesShow less
    • Study sites: 25 to 36
    • Start date changed from estimate of Apr 15, 2024 to Mar 21, 2024
    • Eligibility criteria revised
    • Secondary endpoints revised (23)

    See this version in full on ClinicalTrials.gov ↗

  22. Minor Eligibility criteria revised Secondary endpoints revised (23)v2 Show 1 more changeShow less
    • Secondary endpoints revised (23)

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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.
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
Trial Details
NCT Number NCT06297226
Lead Sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Conditions Multiple Myeloma
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov