Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Study acronym: MajesTEC-4
StatusRecruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 6 of 7 entries
    • Site details revised at 22 of 212 sites
  2. Study sites: 211 to 212v20
  3. Study sites: 210 to 211v19
  4. Study sites: 208 to 210v18
  5. Study sites: 206 to 208v17
Show 15 earlier versionsHide 15 earlier versions
  1. Lead sponsor: Stichting European Myeloma Network to European Myeloma Network B.V.
    • Study sites: 207 to 206
    v16
  2. Study sites: 208 to 207v15
  3. Study sites: 209 to 208v14
  4. Study sites: 210 to 209v13
  5. Study sites: 211 to 210v12
  6. Site details revised at 1 of 211 sitesv11
  7. Primary endpoints: 1 to 2
    • Study sites: 210 to 211
    v10
  8. Enrollment target: 1572 to 1594
    • Study sites: 131 to 210
    v9
  9. Study sites: 115 to 131v8
  10. Study sites: 29 to 115v7
  11. Lead sponsor: European Myeloma Network B.V. to Stichting European Myeloma Networkv6
  12. Enrollment target: 1530 to 1572
    • Study sites: 18 to 29
    • Primary completion date: Oct 2028 to Apr 2028
    • Study completion date: Nov 2031 to Apr 2032
    v5
  13. Start date: Apr 12, 2022 to Sep 8, 2022
    • Enrollment target: 1500 to 1530
    • Study completion date: Dec 2031 to Nov 2031
    v4
  14. Enrollment target: 1000 to 1500v3 Show 7 more changesShow less
    • Primary completion date: Aug 2027 to Oct 2028
    • Study completion date: Nov 2032 to Dec 2031
    • Interventions: Lenalidomide (Drug), Lenalidomide (Drug), Teclistamab (Drug) to Lenalidomide (Drug), Teclistamab (Drug)
    • Secondary endpoints: 8 to 7
    • Study arms: 2 to 3
    • Eligibility criteria shortened, about 1 word
    • Study title expanded, about 4 words
  15. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 14 to 18
    • Start date changed from estimate of Apr 2022 to Apr 12, 2022
    v2
  1. Study First Submitted
  • 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 is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
Trial Details
NCT Number NCT05243797
Lead Sponsor European Myeloma Network B.V.
Collaborators: Janssen Pharmaceutica
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 1,594 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov