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Elotuzumab in Combination With Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) Versus KRd in MM

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor 2 versions Re-verified since Apr 26, 2023, no change to tracked fieldsv10-v11
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 56 of 56 sites
    v9
  3. Minor Study sites revised (56)v8
  4. Minor Site details revised at 4 of 56 sitesv7
  5. Minor Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Site details revised at 1 of 56 sitesv5
  2. Minor Study sites: 1 to 56
    • Collaborators: 1 to 2
    v4
  3. Minor Secondary endpoints: 4 to 3v3
  4. Minor Secondary endpoints: 3 to 4v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Of the next-generation compounds, the monoclonal antibodies (moAbs) have recently attracted a lot of interest in MM. The anti-SLAMF7 directed moAb elotuzumab has completed phase III trials in MM patients. One phase III trial in MM patients with one to three prior lines of therapy compared elotuzumab-Rd with standard Rd. The triple combination was shown to significantly prolong PFS in this patient cohort with a greater proportion of patients in at least very good partial response (VGPR) when compared to subjects on Rd. Notably, the rate of infusion-related reactions with this specific moAb was very low, with an overall rate of 10% in premedicated patients and only 1% of Grade 3 severity. Grades 4/5 infusion-related reactions were absent and only 1% of patients on elotuzumab discontinued for infusion-related reactions. Of particular interest is the observation in this trial, that response and PFS were independent of cytogenetic high-risk features, i.e., deletion of chromosome 17p and translocation t(4;14). This effect distinguishes elotuzumab from most, if not all, other drug-based approaches. The investigators assume that incorporating the moAb into the KRd triple induction regimen should result in an even higher rate of deep (negative for MRD in conjunction with at least very good partial response \[VGPR\] as defined by the International Myeloma Working Group \[IMWG\]) with these responses occurring independently of cytogenetic risk. Due to potential interference of elotuzumab with serum immune fixation, the investigators chose VGPR rather than complete response (CR) to exclude false-positive immunofixation results. Furthermore the investigators hypothesize that combining elotuzumab with lenalidomide should prolong PFS further.
Trial Details
NCT Number NCT03948035
Lead Sponsor Wuerzburg University Hospital
Collaborators: ClinAssess GmbH, Arbeitsgemeinschaft medikamentoese Tumortherapie
Conditions
(from sponsor)
Newly Diagnosed Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 576 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov