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IFM 2024_06NCT06931704

Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly Diagnosed Myeloma (ElMMA)

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Nov 30, 2030 to Nov 30, 2028 Show 5 more changesShow less
    • Eligibility criteria expanded, about 40 words
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study sites: 36 to 35
    • Start date changed from estimate of May 1, 2025 to Jul 9, 2025
    • Secondary endpoints: details revised at 3 of 9 entries
  2. Study title expanded, about 1 wordv2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Minimal Residual Disease negativity rate
Timeframe: At the beginning of cycle 13 (each cycle is 28 days)

Secondary (9)

Safety and tolerability of Dara-Len and Elra-Len
Progression-free survival
Minimal Residual Disease negativity with the threshold evaluated at one year after randomisation
Minimal Residual Disease negativity with the threshold evaluated at one two years
Sustained Minimal Residual Disease negativity
Show 4 moreShow less
Complete Response or better
Overall survival
Progression-free survival 2
Ability of return to work

Arms and interventions

Usual care : Daratumumab + LenalidomideActive comparator
Comparative treatment : Elranatamab + LenalidomideExperimental

Drugs: Elranatamab, Daratumumab, Lenalidomide

Sites

35 sites in 1 country