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Sequential Therapy in Multiple Myeloma Guided by MRD Assessments

Study acronym: MASTER-2
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Dec 2027 → Sep 2028
See other at-risk trials from University of Alabama at Birmingham

Record History

  1. Primary completion pushed from Dec 2027 to Sep 2028 Enrollment closed, study ongoing · Eligibility criteria expanded, about 82 words · Secondary endpoints: details revised at 1 of 3 entries · 1 more Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 82 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 10 of 10 sites
  2. Re-verified, no change to tracked fieldsv22
  3. Primary completion pushed from Dec 2026 to Dec 2027 Completion pushed from Dec 2027 to Dec 2029v21 Show 1 more changeShow less
    • Completion pushed from Dec 2027 to Dec 2029
  4. Site details revised at 1 of 10 sites Collaborators: 2 to 3v20 Show 1 more changeShow less
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 10 sitesv19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 9 to 10v18
  2. Site contacts updated at 8 of 9 sitesv17
  3. Study sites: 1 to 9 Collaborators revised (2)v16 Show 1 more changeShow less
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  4. Collaborators: 1 to 2v15 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv14
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 30, 2023 to Dec 13, 2023v13 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 30, 2023 to Dec 13, 2023
  7. Start date: Nov 30, 2023 to Dec 30, 2023v12
  8. Start date: Oct 30, 2023 to Nov 30, 2023v11
  9. Start date: Sep 2023 to Oct 30, 2023v10
  10. Start date: Jul 2023 to Sep 2023v9
  11. Start date: May 2023 to Jul 2023v8
  12. Start date: Feb 2023 to May 2023v7
  13. Start date: Dec 2022 to Feb 2023v6
  14. Re-verified, no change to tracked fieldsv5
  15. Primary completion date: Apr 2026 to Dec 2026 Start date: Aug 2022 to Dec 2022 · Completion date: Apr 2027 to Dec 2027v4 Show 2 more changesShow less
    • Start date: Aug 2022 to Dec 2022
    • Completion date: Apr 2027 to Dec 2027
  16. Start date: Apr 2022 to Aug 2022 Primary completion date: Dec 2025 to Apr 2026 · Completion date: Dec 2026 to Apr 2027v3 Show 2 more changesShow less
    • Primary completion date: Dec 2025 to Apr 2026
    • Completion date: Dec 2026 to Apr 2027
  17. Re-verified, no change to tracked fieldsv2
  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.
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.
Trial Details
NCT Number NCT05231629
Lead Sponsor University of Alabama at Birmingham
Collaborators: Janssen Scientific Affairs, LLC, Sarah Cannon, coMMit, Myeloma Trials, Innovated
Conditions Multiple Myeloma
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov