Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study

No randomized trial has directly compared daratumumab and lenalidomide (D-R) maintenance with standard-of-care lenalidomide (R) alone after transplant. Herein, we report the primary results of the phase 3 AURIGA study evaluating D-R vs R maintenance in patients with newly diagnosed multiple myeloma (NDMM) who had very good or better partial response, were minimal residual disease (MRD)-positive (10-5) and anti-CD38-naïve after transplant. Two hundred patients were randomly assigned (1:1) to D-R (n = 99) or R (n = 101) maintenance for up to 36 cycles. The MRD-negative (10-5) conversion rate by 12 months from start of maintenance (primary end point) was significantly higher for D-R than R (50.5% vs 18.8%; odds ratio [OR], 4.51; 95% confidence interval [CI], 2.37-8.57; P < .0001). MRD-negative (10-6) conversion rate was similarly higher with D-R (23.2% vs 5.0%; OR, 5.97; 95% CI, 2.15-16.58; P = .0002). At median follow-up (32.3 months), D-R achieved a higher overall MRD-negative (10-5) conversion rate (D-R, 60.6% vs R, 27.7%; OR, 4.12; 95% CI, 2.26-7.52; P < .0001) and complete response rate or better (75.8% vs 61.4%; OR, 2.00; 95% CI, 1.08-3.69; P = .0255) vs R. Progression-free survival (PFS) favored D-R vs R (hazard ratio, 0.53; 95% CI, 0.29-0.97); estimated 30-month PFS rates were 82.7% for D-R and 66.4% for R. Incidences of grade 3/4 cytopenias (54.2% vs 46.9%) and infections (18.8% vs 13.3%) were slightly higher with D-R than R. In conclusion, D-R maintenance achieved a higher MRD-negative conversion rate and improved PFS after transplant vs R, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT03901963.

Authors

Institutions

Publication Details

Journal
Blood
Published
2024-09-27
DOI
https://doi.org/10.1182/blood.2024025746
Citations
43
Primary Topic
Multiple Myeloma Research and Treatments
Type
article
Field-Weighted Citation Impact
19.54

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study

Andrew J. Cowan, Laahn Foster, Rebecca Silbermann, Erin Pettijohn et al.
43 citations
Blood
Multiple Myeloma Research and Treatments
19.54
article

Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study

Andrew J. Cowan, Laahn Foster, Rebecca Silbermann, Erin Pettijohn, Larry D. Anderson, Sarah Marie Larson, Huiling Pei, Kenneth H. Shain, Douglas W. Sborov, Nina Shah, Robin L. Carson, Vipin Khare, Ashraf Badros, Annelore Cortoos, Peter Michael Voorhees, Chakra P. Chaulagain, Alfred Chung, Sharmila Patel, Maria Krevvata, Caitlin Costello, Thomas S. Lin
article en
43 citations

Abstract

No randomized trial has directly compared daratumumab and lenalidomide (D-R) maintenance with standard-of-care lenalidomide (R) alone after transplant. Herein, we report the primary results of the phase 3 AURIGA study evaluating D-R vs R maintenance in patients with newly diagnosed multiple myeloma (NDMM) who had very good or better partial response, were minimal residual disease (MRD)-positive (10-5) and anti-CD38-naïve after transplant. Two hundred patients were randomly assigned (1:1) to D-R (n = 99) or R (n = 101) maintenance for up to 36 cycles. The MRD-negative (10-5) conversion rate by 12 months from start of maintenance (primary end point) was significantly higher for D-R than R (50.5% vs 18.8%; odds ratio [OR], 4.51; 95% confidence interval [CI], 2.37-8.57; P < .0001). MRD-negative (10-6) conversion rate was similarly higher with D-R (23.2% vs 5.0%; OR, 5.97; 95% CI, 2.15-16.58; P = .0002). At median follow-up (32.3 months), D-R achieved a higher overall MRD-negative (10-5) conversion rate (D-R, 60.6% vs R, 27.7%; OR, 4.12; 95% CI, 2.26-7.52; P < .0001) and complete response rate or better (75.8% vs 61.4%; OR, 2.00; 95% CI, 1.08-3.69; P = .0255) vs R. Progression-free survival (PFS) favored D-R vs R (hazard ratio, 0.53; 95% CI, 0.29-0.97); estimated 30-month PFS rates were 82.7% for D-R and 66.4% for R. Incidences of grade 3/4 cytopenias (54.2% vs 46.9%) and infections (18.8% vs 13.3%) were slightly higher with D-R than R. In conclusion, D-R maintenance achieved a higher MRD-negative conversion rate and improved PFS after transplant vs R, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT03901963.

BloodVol. 145(3)
University of Maryland, Baltimore (US), Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa (ZA), Johnson & Johnson (United States) (US), University of California, Los Angeles (US), Oregon Health & Science University (US), University of California, San Francisco (US), University of Utah (US), Huntsman Cancer Institute (US), Moffitt Cancer Center (US), University of California San Diego (US), Fred Hutch Cancer Center (US), University of Santa Monica (US), Levine Cancer Institute (US), Springhouse (US), Cleveland Clinic Florida (US), Amyloidosis Foundation (US), Hematology Oncology Consultants (US), Janssen (United States) (US), Janssen Scientific Affairs (United States), University of Virginia (US), University of Baltimore (US), University of San Francisco (US), The University of Texas Southwestern Medical Center (US)
Amgen, Bristol-Myers Squibb, Pfizer, AstraZeneca, Sanofi, Celgene, Regeneron Pharmaceuticals, Prothena, Adaptive Biotechnologies, BeiGene, Genentech, Sanofi Genzyme, Janssen Biotech
Good health and well-being
Openalex Percentile: Top 0%
Multiple Myeloma Research and Treatments
19.54
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.