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EHA 2025 | PREDATOR-MRD trial results: daratumumab versus observation following MRD reappearance in myeloma
Krzysztof Jamroziak, MD, Medical University of Warsaw, Warsaw, Poland, presents the results of the PREDATOR-MRD trial (NCT03697655), a Phase II study evaluating the efficacy of single-agent daratumumab versus observation in patients with measurable residual disease (MRD) recurrence of multiple myeloma (MM). Dr Jamroziak highlights that daratumumab significantly delays clinical progression or significant paraprotein progression, and demonstrates good tolerability. This study serves as proof of concept for future clinical trials with modern MRD assessment techniques and novel therapies. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
PREDATOR-MRD study is a Phase two multi-center randomized study assessing single agent daratumumab versus observation in patients with MRD recurrence of multiple myeloma. The main inclusion criteria was completion of one or two lines of therapy, achieving MRD-negative complete remission and maintaining this response at the time of screening, not receiving any antimyeloma therapy at the time of screening, and the main exclusion criteria was previous treatment with anti-CD38 antibody...
PREDATOR-MRD study is a Phase two multi-center randomized study assessing single agent daratumumab versus observation in patients with MRD recurrence of multiple myeloma. The main inclusion criteria was completion of one or two lines of therapy, achieving MRD-negative complete remission and maintaining this response at the time of screening, not receiving any antimyeloma therapy at the time of screening, and the main exclusion criteria was previous treatment with anti-CD38 antibody. Eligible patients were included to MRD reappearance observation phase where we tested MRD by flow cytometry with sensitivity 10 to minus 5 every 4 months for 6 times. Patients who turned out to be MRD positive and did not meet criteria of clinical relapse or significant paraprotein relapse were randomized to daratumumab or observation.
We included 54 patients to the MRD observation reappearance phase, of which 24 were randomized to daratumumab or observation, 12 patients in each group. Daratumumab was given 16 mg per kg IV, then changed to 1800 mg sub-Q, weekly for 8 doses, then every 2 weeks for 8 doses and monthly for 24 weeks. Patients in the observation arm were followed for response every 4 weeks.
We found that three patients were found with significant paraprotein relapse or clinical relapse in daratumumab arm and nine patients in observation arm. Hazard ratio for patients in the daratumumab arm for significant paraprotein relapse or clinical progression was 0.2.
So in summary, daratumumab delays clinical progression or significant paraprotein progression in patients with MRD recurrence in multiple myeloma. It has very good tolerance and does not decrease quality of life. And our small trial can be treated as a proof of concept study for future clinical trials with modern MRD assessment techniques and novel therapies..
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Disclosures
Research Support: Janssen, AbbVie; Advisory Boards: AbbVie, Beigene, Janssen, Takeda, Pfizer, GSK, Sanofi, Amgen; Lectures and educational events: AbbVie, BeiGene, Janssen, Takeda, Pfizer, GSK, Sanofi, Amgen.
