A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

Study acronym: MagnetisMM-6
StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

The 50 most recent of 63 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 139 → 160 locations
    • Enrollment target: 1116 to 1060
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 18 entries
  2. Trial sites expanded: 127 → 139 locationsv62
  3. Trial sites expanded: 121 → 127 locationsv61
  4. Trial sites expanded: 111 → 121 locationsv60
  5. Trial sites expanded: 89 → 111 locationsv59
  6. Trial sites expanded: 39 → 89 locationsv58
  7. Trial sites reduced: 89 → 39 locationsv57
  8. Site details revised at 5 of 89 sitesv56
  9. Primary endpoint(s) modifiedv55 Show 5 more changesShow less
    • Study sites: 88 to 89
    • Interventions: Daratumumab (Drug), Dexamethasone (Drug), Elranatamab (Drug), Lenalidomide (Drug) to Bortezomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Elranatamab (Drug), Lenalidomide (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (18)
    • Study title shortened, about 8 words
  10. Study sites revised (88)v54
  11. Study sites: 85 to 88v53
  12. Study sites revised (85)v52
  13. Study sites: 86 to 85v51
  14. Primary completion date: Mar 31, 2028 to Oct 18, 2030v50 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 966 to 1116
    • Study sites: 85 to 86
    • Study completion date: Nov 29, 2031 to Oct 3, 2033
    • Secondary endpoints revised (18)
    • Study arms: 6 to 5
    • Study title expanded, about 5 words
  15. Study sites: 76 to 85v49
  16. Study sites: 73 to 76v48
  17. Study sites: 66 to 73v47
  18. Study sites: 65 to 66v46
  19. Study sites: 66 to 65v45
  20. Re-verified, no change to tracked fieldsv44
  21. Study sites: 65 to 66v43
  22. Site details revised at 1 of 65 sitesv42
  23. Site details revised at 3 of 65 sitesv41
  24. Re-verified, no change to tracked fieldsv40
  25. Study sites: 64 to 65v39
  26. 2 versions Re-verified since Apr 9, 2025, no change to tracked fieldsv37-v38
  27. Study sites: 73 to 64v36
  28. Site details revised at 1 of 73 sitesv35
  29. Site details revised at 1 of 73 sitesv34
  30. Enrollment target: 1116 to 966
    • Site details revised at 1 of 73 sites
    v33
  31. Study sites: 72 to 73v32
  32. Primary endpoints revised (3)v31 Show 4 more changesShow less
    • Enrollment target: 966 to 1116
    • Secondary endpoints: 19 to 18
    • Site details revised at 3 of 72 sites
    • Study arms: 4 to 6
  33. Re-verified, no change to tracked fieldsv30
  34. Study sites: 70 to 72v29
  35. Study sites: 66 to 70v28
  36. Study sites: 61 to 66v27
  37. Site details revised at 2 of 61 sitesv26
  38. Study sites: 59 to 61v25
  39. Study sites: 55 to 59v24
  40. Study sites: 53 to 55v23
  41. Study sites: 51 to 53v22
  42. Study sites: 48 to 51v21
  43. Study sites: 42 to 48v20
  44. Study sites: 38 to 42v19
  45. Study sites: 36 to 38v18
  46. Study sites: 33 to 36v17
  47. Study sites: 28 to 33v16
  48. Study sites: 25 to 28v15
  49. Study sites: 23 to 25
    • Primary completion date: Jul 2, 2028 to Mar 31, 2028
    • Study completion date: Jul 2, 2028 to Nov 29, 2031
    • Secondary endpoints: 18 to 19
    v14
  • 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.
Pfizer
438 trials monitored
See 32 trials at risk
Multiple Myeloma
1,264 trials monitored
See 78 trials at risk
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Trial Details
NCT Number NCT05623020
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 1,060 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov