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

Official Title

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

Summary:

The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.

Trial Description

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 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. 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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society