Details

Autor(en) / Beteiligte

• Voorhees, Peter M.
• Kaufman, Jonathan L.
• Laubach, Jacob
• Sborov, Douglas W.
• Reeves, Brandi
• Rodriguez, Cesar
• Chari, Ajai
• Silbermann, Rebecca
• Costa, Luciano J.
• Anderson, Larry D.
• Nathwani, Nitya
• Shah, Nina
• Efebera, Yvonne A.
• Holstein, Sarah A.
• Costello, Caitlin
• Jakubowiak, Andrzej
• Wildes, Tanya M.
• Orlowski, Robert Z.
• Shain, Kenneth H.
• Cowan, Andrew J.
• Murphy, Sean
• Lutska, Yana
• Pei, Huiling
• Ukropec, Jon
• Vermeulen, Jessica
• de Boer, Carla
• Hoehn, Daniela
• Lin, Thomas S.
• Richardson, Paul G.

Titel

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

Ist Teil von

• Blood, 2020-08, Vol.136 (8), p.936-945

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2020

Quelle

MEDLINE

Beschreibungen/Notizen

• Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The addition of daratumumab (D) to RVd (D-RVd) in transplant-eligible NDMM patients was evaluated. Patients (N = 207) were randomized 1:1 to D-RVd or RVd induction (4 cycles), ASCT, D-RVd or RVd consolidation (2 cycles), and lenalidomide or lenalidomide plus D maintenance (26 cycles). The primary end point, stringent complete response (sCR) rate by the end of post-ASCT consolidation, favored D-RVd vs RVd (42.4% vs 32.0%; odds ratio, 1.57; 95% confidence interval, 0.87-2.82; 1-sided P = .068) and met the prespecified 1-sided α of 0.10. With longer follow-up (median, 22.1 months), responses deepened; sCR rates improved for D-RVd vs RVd (62.6% vs 45.4%; P = .0177), as did minimal residual disease (MRD) negativity (10−5 threshold) rates in the intent-to-treat population (51.0% vs 20.4%; P < .0001). Four patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group progressed; respective 24-month progression-free survival rates were 95.8% and 89.8%. Grade 3/4 hematologic adverse events were more common with D-RVd. More infections occurred with D-RVd, but grade 3/4 infection rates were similar. Median CD34+ cell yield was 8.2 × 106/kg for D-RVd and 9.4 × 106/kg for RVd, although plerixafor use was more common with D-RVd. Median times to neutrophil and platelet engraftment were comparable. Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT02874742. •D-RVd improved sCR rates and MRD negativity vs RVd, both of which deepened over time.•No new safety concerns were observed with D-RVd, and no clinically significant impact on stem cell mobilization or engraftment was noted. [Display omitted]