Daratumumab plus RVd for newly diagnosed multiple myeloma: Final analysis of the safety run-in cohort of GRIFFIN

Peter M. Voorhees, Cesar Rodriguez, Brandi Reeves, Nitya Nathwani, Luciano J. Costa, Yana Lutska, Padma Bobba, Daniela Hoehn, Huiling Pei, Jon Ukropec, Ming Qi, Thomas S. Lin, Paul G. Richardson

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

Abstract

The phase 2 GRIFFIN study of daratumumab plus lenalidomide/bortezomib/dexamethasone (D-RVd) for transplant-eligible, newly diagnosed multiple myeloma included a safety run-in phase followed by a randomized phase. The ongoing randomized phase has met its prespecified primary end point of an improved stringent complete response (sCR) rate after consolidation for D-RVd (reported elsewhere). Final analysis of the safety run-in cohort is reported herein and provides longer follow-up (median, 40.8 months) encompassing daratumumab plus lenalidomide (D-R) maintenance therapy. Patients in the safety run-in cohort (N 5 16) received 4 induction cycles (D-RVd), high-dose melphalan supported by autologous stem cell transplant, 2 consolidation cycles (D-RVd), and 24 months of maintenance (D-R). By the end of consolidation, all patients had responded, with a best response of sCR in 9 (56.3%) patients; 8 (50.0%) patients were minimal residual disease (MRD) negative (10?5 threshold). After maintenance, 15 (93.8%) patients had achieved a best response of sCR, and 13 (81.3%) patients were MRD (10?5) negative. Estimated 36-month progression-free and overall survival rates were 78.1% and 93.8%, respectively. One death from progressive disease occurred in the patient who did not achieve sCR. Observed safety profiles were consistent with daratumumab and RVd. With .3 years of median follow-up, D-RVd achieved durable responses that deepened with D-R maintenance. This study was registered at www.clinicaltrials.gov as #NCT02874742.

Original languageEnglish
Pages (from-to)1092-1096
Number of pages5
JournalBlood advances
Volume5
Issue number4
DOIs
StatePublished - 23 Feb 2021
Externally publishedYes

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