Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Minor Study completion date: Dec 2025 to Dec 2026v22
  2. Minor Study completion date: Dec 2024 to Dec 2025v21
  3. Minor Study completion date: Sep 2024 to Dec 2024v20
  4. Minor Study completion date: Dec 2023 to Sep 2024v19
  5. Minor Study completion date: Feb 2023 to Dec 2023v18
Show 16 earlier versionsHide 16 earlier versions
  1. Minor Study completion date: Feb 2022 to Feb 2023v17
  2. Minor Study completion date: Feb 2021 to Feb 2022v16
  3. 2 versions Re-verified since Jan 29, 2020, no change to tracked fieldsv14-v15
  4. Minor Study completion date: Feb 2019 to Feb 2021v13
  5. Re-verified, no change to tracked fieldsv12
  6. Minor Study completion date: Feb 2016 to Feb 2019v11
  7. Re-verified, no change to tracked fieldsv10
  8. Minor Secondary endpoints: details revised at 3 of 3 entriesv9
  9. Notable Results first posted: Aug 19, 2014v8 Show 6 more changesShow less
    • Primary completion date: Jul 2012 to Jul 2009
    • Primary endpoints: 2 to 1
    • Enrollment target: estimated 87 to confirmed 68
    • Start date: Aug 2006 to Sep 2006
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 1 to 3
  10. Notable Primary completion date changed from estimate of Dec 2010 to Jul 2012
    • Study completion date: Dec 2011 to Feb 2016
    • Study arms: 0 to 1
    v7
  11. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 2010 to Dec 2010
    • Study completion date: Aug 2010 to Dec 2011
    • Site details revised at 3 of 3 sites
    v6
  12. Notable Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Aug 2009 to Aug 2010
    • Site details revised at 3 of 3 sites
    v5
  13. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v4
  14. Minor Primary and study completion dates: Aug 2009
    • Interventions: Bortezomib (Drug), Lenalidomide (Drug) to Bortezomib (Drug), Lenalidomide (Drug), dexamethasone (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    v3
  15. Re-verified, no change to tracked fieldsv2
  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.
The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.
Trial Details
NCT Number NCT00378105
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Celgene Corporation, Millennium Pharmaceuticals, Inc.
Conditions
(from sponsor)
Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov