Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. 3 versions Re-verified since Mar 11, 2025, no change to tracked fieldsv36-v38
  2. Study completion date: Jun 28, 2024 to Jun 28, 2026v35
  3. 2 versions Re-verified since Feb 15, 2024, no change to tracked fieldsv33-v34
  4. Study completion date: Feb 28, 2023 to Jun 28, 2024
    • Start date: Aug 2006 to Aug 2, 2006
    v32
  5. Re-verified, no change to tracked fieldsv31
Show 29 earlier versionsHide 29 earlier versions
  1. Results first posted: May 4, 2022
    • Primary endpoints: 1 to 3
    • Enrollment target: estimated 38 to confirmed 46
    • Study completion date: Feb 28, 2021 to Feb 28, 2023
    v30
  2. Primary completion date: Feb 2020 to Feb 28, 2021
    • Study completion date: Feb 2021 to Feb 28, 2021
    v29
  3. Study completion date: Feb 2020 to Feb 2021v28
  4. Re-verified, no change to tracked fieldsv27
  5. Primary completion date: Feb 2018 to Feb 2020
    • Study completion date: Feb 2020
    v26
  6. Primary completion date: Feb 2017 to Feb 2018v25
  7. Primary completion date: Feb 2016 to Feb 2017v24
  8. Primary completion date: Feb 2015 to Feb 2016
    • Study site revised
    v23
  9. Study description expanded, about 261 wordsv22
  10. Re-verified, no change to tracked fieldsv21
  11. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v20
  12. Primary completion date: Feb 2014 to Feb 2015v19
  13. Re-verified, no change to tracked fieldsv18
  14. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v17
  15. Re-verified, no change to tracked fieldsv16
  16. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v15
  17. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Feb 2013 to Feb 2014
    • Site details revised
    v14
  18. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v13
  19. 2 versions Re-verified since Aug 24, 2011, no change to tracked fieldsv11-v12
  20. Primary completion date: Feb 2012 to Feb 2013v10
  21. Primary completion date: Feb 2011 to Feb 2012
    • Study description shortened, about 262 words
    v9
  22. Study site revisedv8
  23. Primary completion date: Aug 2010 to Feb 2011v7
  24. Secondary endpoints shortened, about 16 wordsv6
  25. Primary completion date: Aug 2009 to Aug 2010
    • Primary endpoint revised
    • Interventions: Bortezomib (Drug), Rituximab (Drug) to Bortezomib (Drug), Rituximab (Drug), Valacyclovir (Drug)
    v5
  26. Secondary endpoint revisedv4
  27. Primary endpoints: 2 to 1v3 Show 5 more changesShow less
    • Primary completion date: Aug 2009
    • Study completion date: Mar 2008 to not stated
    • Secondary endpoints: 3 to 1
    • Study description shortened, about 42 words
    • Study title revised
  28. Study completion date: Mar 2008
    • Study arms: 0 to 1
    • Study title shortened, about 1 word
    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.
The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given with rituximab can help to control WM. This drug combination will allow researchers to collect your stem cells in case it is possible to transplant the stem cells as treatment if your WM gets worse. Researchers will also look at the safety and tolerability of this drug combination followed by treatment with other drug combinations.
Trial Details
NCT Number NCT00492050
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Millennium Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Waldenstrom's Macroglobulinemia
Related terms Waldenstrom Macroglobulinemia
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov