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UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary completion date: Oct 2026 to Oct 2027
    • Study completion date: Oct 2027 to Oct 2028
    v21
  2. Notable Primary completion date: Oct 2025 to Oct 2026
    • Study completion date: Oct 2026 to Oct 2027
    v20
  3. Notable Primary completion date: Oct 2024 to Oct 2025
    • Study completion date: Oct 2024 to Oct 2026
    v19
  4. Notable Primary and study completion dates: Oct 2023 to Oct 2024v18
  5. Notable Primary and study completion dates: Oct 2022 to Oct 2023v17
Show 15 earlier versionsHide 15 earlier versions
  1. Notable Primary and study completion dates: Oct 2021 to Oct 2022v16
  2. Notable Primary and study completion dates: Oct 2020 to Oct 2021v15
  3. Notable Primary and study completion dates: Oct 2019 to Oct 2020v14
  4. Minor Re-verified, no change to tracked fieldsv13
  5. Notable Primary and study completion dates: Oct 2017 to Oct 2019
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    v12
  6. Notable Primary and study completion dates: Oct 2016 to Oct 2017
    • Interventions: Velcade (Drug) to Adriamycin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Dexamethasone (Drug), Etoposide (Drug), Melphalan (Drug), Thalidomide (Drug)…
    • Study arms: 0 to 1
    v11
  7. Minor Study title expanded, about 2 wordsv10
  8. Notable Primary and study completion dates: Oct 2015 to Oct 2016v9
  9. Notable Primary and study completion dates: Oct 2013 to Oct 2015v8
  10. Minor Re-verified, no change to tracked fieldsv7
  11. Notable Primary and study completion dates: Oct 2012 to Oct 2013v6
  12. Minor Re-verified, no change to tracked fieldsv5
  13. Notable Primary endpoint revised
    • Secondary endpoint revised
    v4
  14. Notable Primary completion date: Oct 2010 to Oct 2012
    • Study completion date: Oct 2011 to Oct 2012
    v3
  15. Minor Study Identification, Study Statusv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy. Past studies conducted at the MIRT and at other institutions have shown that participants with high-risk features by gene array studies tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. Researchers at MIRT think that one reason for this is that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.
Trial Details
NCT Number NCT00869232
Lead Sponsor University of Arkansas
Conditions
(from sponsor)
Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov