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Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 62 words Show 4 more changesShow less
    • Secondary endpoints: details revised at 1 of 17 entries
    • Study description revised
    • Site details revised at 63 of 920 sites
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Nov 30, 2025 to Dec 31, 2026v17
  3. Re-verified, no change to tracked fieldsv16
  4. Primary completion date: Nov 1, 2023 to Nov 30, 2025v15
  5. Start date: Dec 2, 2013 to Dec 6, 2013v14
Show 12 earlier versionsHide 12 earlier versions
  1. 2 versions Re-verified since Dec 29, 2021, no change to tracked fieldsv12-v13
  2. Study completion date: Feb 5, 2034v11
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1080 to confirmed 1087
    • Site details revised at 920 of 920 sites
    v10
  4. Study sites: 846 to 920
    • Secondary endpoints revised (17)
    v9
  5. Primary endpoints: 1 to 2v8 Show 9 more changesShow less
    • Enrollment target: 756 to 1080
    • Study sites: 676 to 846
    • Primary completion date: Nov 2023 to Nov 1, 2023
    • Study completion date: Nov 2028 to not stated
    • Start date: Nov 2013 to Dec 2, 2013
    • Interventions: bortezomib (Drug), carfilzomib (Drug), dexamethasone (Drug), laboratory biomarker analysis (Other), lenalidomide (Drug), quality-of-life… to Bortezomib (Drug), Carfilzomib (Drug), Dexamethasone (Drug), Laboratory Biomarker Analysis (Other), Lenalidomide (Drug), Quality-of-Life…
    • Eligibility criteria expanded, about 524 words
    • Secondary endpoints revised (17)
    • Study description expanded, about 120 words
  6. Primary completion date: Nov 2024 to Nov 2023
    • Study completion date: Nov 2028
    • Site details revised at 1 of 676 sites
    v7
  7. Primary completion date: May 2016 to Nov 2024
    • Site details revised at 2 of 676 sites
    v6
  8. Study sites: 639 to 676v5
  9. Lead sponsor: Eastern Cooperative Oncology Group to ECOG-ACRIN Cancer Research Group
    • Study sites: 1 to 639
    v4
  10. Re-verified, no change to tracked fieldsv3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. 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.
This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma
Trial Details
NCT Number NCT01863550
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Plasma Cell Myeloma
Related terms Multiple Myeloma
Enrollment 1,087 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov