Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 20 participants (planned 17)
    • Study completion date changed from estimate of May 2026 to May 27, 2026
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: details revised at 1 of 7 entries
  2. Enrollment target: 20 to 17
    • Primary completion date changed from estimate of May 2025 to May 20, 2025
    v9
  3. Trial status: Recruiting to Active, Not Recruitingv8 Show 4 more changesShow less
    • Enrollment target: 18 to 20
    • Primary completion date: Dec 2024 to May 2025
    • Study completion date: Jun 2025 to May 2026
    • Site details revised
  4. Enrollment target: 38 to 18
    • Primary completion date: Feb 2024 to Dec 2024
    • Study completion date: Jun 2024 to Jun 2025
    v7
  5. Primary completion date: Feb 2023 to Feb 2024
    • Study completion date: Jun 2028 to Jun 2024
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Lead sponsor: Ajai Chari to Larysa Sanchez
    • Site contact updated
    v5
  2. Primary completion date: Aug 2021 to Feb 2023
    • Study completion date: Dec 2021 to Jun 2028
    v4
  3. Eligibility criteria expanded, about 124 words
    • Study description revised
    • Site contact updated
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2019 to Oct 24, 2019
    • Site details revised
    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.
This is a single center, open-label, phase 2 study in elderly (age ≥ 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible. Subjects will receive subcutaneous daratumumab, dose-attenuated bortezomib, revlimid, and dexamethasone until confirmed disease progression, discontinuation of study treatment due to unacceptable drug toxicity, or other reasons. Throughout the study, subjects will be monitored closely for adverse events, laboratory abnormalities, and clinical response.
Trial Details
NCT Number NCT04052880
Lead Sponsor Larysa Sanchez
Collaborators: Janssen, LP
Conditions
(from sponsor)		 Newly Diagnosed Multiple Myeloma
Related terms Multiple Myeloma, Neoplasms, Plasma Cell
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov