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MoMMentNCT05160584

A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)
Track this trial

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Record History

The 50 most recent of 66 versions: 38 with changes below, 12 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Final enrollment: 256 participants (planned 300)
    • Site details revised at 90 of 90 sites
  2. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 8 of 20 entries
    • Site details revised at 2 of 90 sites
    • Publications: details revised at 3 of 3 entries
  3. Study completion pushed from Jul 31, 2028 to Oct 30, 2028
    • Study sites: 89 to 90
    v63
  4. Study sites: 87 to 89v62
  5. Study sites: 86 to 87v60
Show 33 earlier versionsHide 33 earlier versions
  1. Study sites: 85 to 86v59
  2. Study sites: 82 to 85
    • Study completion date: May 31, 2028 to Jul 31, 2028
    • Eligibility criteria expanded, about 141 words
    • Secondary endpoints: details revised at 20 of 20 entries
    v56
  3. Study sites: 80 to 82v55
  4. Study sites: 79 to 80
    • Study completion date: Apr 30, 2028 to May 31, 2028
    v54
  5. Study sites: 75 to 79v53
  6. Study sites: 69 to 75v52
  7. Primary completion date: Nov 30, 2024 to Apr 30, 2028
    • Study sites: 60 to 69
    v50
  8. Study sites: 53 to 60v49
  9. Study sites: 52 to 53v47
  10. Study sites: 51 to 52v46
  11. Study sites: 50 to 51v44
  12. Enrollment target: 100 to 300v42 Show 4 more changesShow less
    • Study sites: 49 to 50
    • Study completion date: Dec 31, 2027 to Apr 30, 2028
    • Eligibility criteria expanded, about 221 words
    • Secondary endpoints: 17 to 20
  13. Study completion date: Dec 31, 2028 to Dec 31, 2027v39
  14. Site details revised at 13 of 49 sitesv38
  15. Site details revised at 1 of 49 sitesv37
  16. Study sites: 48 to 49
    • Study completion date: Dec 31, 2026 to Dec 31, 2028
    v36
  17. Study sites revised (48)v35
  18. Study sites revised (48)v34
  19. Study sites revised (48)v33
  20. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 48 of 48 sites
    v32
  21. Primary completion date: Sep 12, 2025 to Nov 30, 2024
    • Study completion date: Oct 5, 2026 to Dec 31, 2026
    • Study sites revised (48)
    v31
  22. Study sites revised (48)v30
  23. Study sites revised (48)v29
  24. Primary completion date: Nov 30, 2024 to Sep 12, 2025
    • Study completion date: Jan 30, 2025 to Oct 5, 2026
    • Study sites revised (48)
    v27
  25. Study sites revised (48)v26
  26. Study sites revised (48)v25
  27. Site details revised at 1 of 48 sitesv24
  28. Primary completion date: Jan 30, 2025 to Nov 30, 2024v22
  29. Study sites revised (48)v21
  30. Study sites revised (48)v20
  31. Study sites revised (48)v19
  32. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 49 to 48
    • Primary completion date: Nov 30, 2024 to Jan 30, 2025
    v18
  33. Primary completion date: Jan 30, 2025 to Nov 30, 2024
    • Study sites revised (49)
    v17
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall Response Rate (ORR)
Timeframe: Up to 52 months

Secondary (20)

Very Good Partial Response (VGPR) Rate
Complete Response (CR) Rate
Stringent Complete Response (sCR) Rate
Minimal Residual Disease (MRD) Negative Rate
Clinical Benefit Rate (CBR)
Show 15 moreShow less
Duration of Response (DOR)
Time to Response (TTR)
Time to Best Response
Time to Next Treatment (TTNT)
Progression-free Survival (PFS)
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)
Overall Survival (OS)
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39
Number of Participants with Adverse Events (AEs)
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS)
Period 3: Percentage of Participants with Overall Response to Subsequent Therapies

Arms and interventions

Participants with Relapsed/Refractory Multiple Myeloma

Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.

Other: No intervention

Sites

90 sites in 12 countries

Italy 21, Spain 16, Germany 12, Greece 9, United Kingdom 7, Belgium 6, France 5, Switzerland 4, Portugal 3, Romania 3, Austria 2, Netherlands 2