Pre-emptive Daratumumab Therapy of Minimal Residual Disease Reappearance or Biochemical Relapse in Multiple Myeloma

Sponsor
Polish Myeloma Consortium
Study ID
NCT03697655
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab 20 MG/ML [Darzalex] — DRUG
    Daratumumab dose 16 mg/kg body weight to be administered as an IV infusion. treatment given until clinical progression or SPR but no longer than 73 weeks

Study Details

PREDATOR is a study investigating a role of preemptive daratumumab therapy for preclinical relapse or progression of multiple myeloma (MM).

Key Dates

Start date
Dec 10, 2018
Status verified
Jan 2019
Primary completion
Sep 30, 2020
Completion
Jul 31, 2024

Study Design

Enrollment
274 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PREDATOR-BR Cohort A
    n=46, Daratumumab 20 MG/ML \[Darzalex\], 16 mg/kg body weight administered as an intravenous infusion
  • No Intervention: PREDATOR-BR Cohort B
    n=46, Control Group, Observation (no treatment)
  • Experimental: PREDATOR-MRD Cohort A
    n=59, Daratumumab 20 MG/ML \[Darzalex\], 16 mg/kg body weight administered as an intravenous infusion
  • No Intervention: PREDATOR-MRD Cohort B
    n=59, Control Group, Observation (no treatment)

Primary Outcome Measure

Event Free Survival (ESF) [ Time Frame: from randomization till the date of development clinical relapse or death from any cause; up to 129 weeks ]

Central Contacts

Related Studies