A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

Titre officiel

A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma

Sommaire:

L’objectif de cette étude consiste à évaluer trois schémas posologiques pour le daratumumab chez les participants atteints d’un myélome multiple latent.

Description de l'essai

Primary Outcome:

  • The percentage of participants who achieve a complete response (CR)
  • The percentage of participants that have an event (disease progression or death) per patient-year
Secondary Outcome:
  • The percentage of participants who are minimal residual disease (MRD) negative
  • Time to next treatment (TNT)
  • The percentage of participants who achieve a Complete Response (CR) or a Partial Response (PR)
  • The median time of progression free survival (PFS)
  • The percentage of participants with symptomatic multiple myeloma
  • Response to first subsequent multiple myeloma treatment
  • Overall survival rate
This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 3-arm (3 treatment groups), multicentre study of daratumumab in participants diagnosed with intermediate or high-risk Smoldering Multiple Myeloma (SMM [ie, early disease without any symptoms]). Participants will be randomized (assigned by chance) to one of 3 treatment groups (arm A [long intense], arm B [intermediate] and arm C [short intense]) to receive daratumumab. Each treatment group will investigate 1 of 3 dosing schedules of daratumumab. The study will include a 28-Day Screening Phase, a Treatment Phase of 1 to 20 treatment cycles (each cycle is 8 weeks in duration for total period of 8 to 160 weeks), and a Follow up Phase of 4-weeks from the last dose of study drug. For participants in Arm A (long intense) and Arm B (intermediate), there is a possibility to extend treatment with intravenous (IV) daratumumab (every 8 weeks [Q8W]) after the end of Cycle 20, as per investigator discretion. The Follow-up Phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. The end of the study will occur approximately 4 years after the last participant enrolled receives a first dose of study drug. Disease assessments will be performed every 8 weeks in the first year and then every 16 weeks until disease progression. Safety will be monitored throughout the study.

Voir cet essai sur ClinicalTrials.gov

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