A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma

Study acronym: COSTA
StatusWithdrawn
PhasePhase 2
Started

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Record History

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  1. Withdrawn before enrolling Sponsor's reason: Due to barriers in anticipated accrual Show 5 more changesShow less
    • Enrollment target: estimated 33 to confirmed 0
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 8 of 10 entries
    • Site contacts updated at 5 of 5 sites
    • Publications: details revised at 14 of 14 entries
  2. Start date: May 2026 to Nov 2026
    • Primary completion pushed from May 2028 to Oct 2028
    • Study completion pushed from Jun 2028 to Nov 2028
    v7
  3. Primary completion date: Oct 2025 to May 2028
    • Start date: Oct 2025 to May 2026
    • Study completion date: Oct 2027 to Jun 2028
    v6
  4. Start date: Jun 2024 to Oct 2025
    • Primary completion date: Sep 2025 to Oct 2025
    • Study completion date: Sep 2027 to Oct 2027
    v5
  5. Start date: Mar 2024 to Jun 2024v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Nov 2023 to Mar 2024v3
  2. Start date: Jun 2023 to Nov 2023
    • Primary completion date: Apr 2025 to Sep 2025
    • Study completion date: Apr 2027 to Sep 2027
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.
Trial Details
NCT Number NCT05874193
Lead Sponsor Cristiana Costa Chase, DO
Conditions
(from sponsor)		 Relapsed/Refractory Multiple Myeloma
Related terms Multiple Myeloma
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov