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GRIFFIN

Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial

Phase 2N = 207NCT02874742

Population
Transplant-eligible newly diagnosed multiple myeloma.
Design
Randomised trial (registered as phase 2): 207 patients were randomised 1:1 to daratumumab plus RVd or RVd induction (4 cycles), autologous stem-cell transplantation, consolidation (2 cycles) and maintenance with lenalidomide alone or with daratumumab (26 cycles). The primary end point was stringent complete response rate by the end of post-transplant consolidation, tested with a one-sided alpha of 0.10.
Primary endpoint
sCR rate
Arms
  • Daratumumab + RVd (experimental): Daratumumab with lenalidomide, bortezomib and dexamethasone induction, transplantation, consolidation and maintenance
  • RVd (control): Lenalidomide, bortezomib and dexamethasone induction, transplantation, consolidation and lenalidomide maintenance
People
Voorhees PM
Δ sCR rate+10.4 pointsΔ sCR rate+17.2 pointsΔ MRD+30.6 pointsΔ 24-month PFS+6 points
Show the numbers
Results reported for GRIFFIN
EndpointAnalysisDaratumumab + RVdRVdEffect
sCR rateRandomised patients (207)primaryVoorhees 202042.4%32%P=0.068 (one-sided)Odds ratio 1.57 (95% CI 0.87 to 2.82). The abstract states that this met the prespecified one-sided alpha of 0.10.
sCR rateRandomised patients (207)long term-updatemedian follow-up 22.1 monthsVoorhees 202062.6%45.4%P=0.0177
MRDIntention-to-treat population (207)long term-updatemedian follow-up 22.1 monthsVoorhees 202051%20.4%P<0.0001
PFSRandomised patients (207)long term-updatemedian follow-up 22.1 monthsVoorhees 202095.8% at 2 y89.8% at 2 yFour patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group had progressed.
Results reported for GRIFFIN
EndpointAnalysisDaratumumab + RVdRVdEffect
sCR rateRandomised patients (207)primaryVoorhees 202042.4%32%P=0.068 (one-sided)Odds ratio 1.57 (95% CI 0.87 to 2.82). The abstract states that this met the prespecified one-sided alpha of 0.10.
sCR rateRandomised patients (207)long term-updatemedian follow-up 22.1 monthsVoorhees 202062.6%45.4%P=0.0177
MRDIntention-to-treat population (207)long term-updatemedian follow-up 22.1 monthsVoorhees 202051%20.4%P<0.0001
PFSRandomised patients (207)long term-updatemedian follow-up 22.1 monthsVoorhees 202095.8% at 2 y89.8% at 2 yFour patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group had progressed.
Primary publication: Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020;136(8):936-945. PubMedDOI

Appears in

Sources

  1. Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020;136(8):936-945.

    PubMedDOI