Abstract: This is a summary of a publication about Black participants of the GRIFFIN clinical study that was published in Blood Cancer Journal in April 2022. The GRIFFIN clinical study looked at the treatment combination of daratumumab plus a standard therapy for multiple myeloma (called RVd therapy, which stands for lenalidomide, bortezomib, and dexamethasone) in adult patients who had not been treated before for multiple myeloma and so were considered to have newly diagnosed multiply myeloma. Multiple myeloma is a blood cancer of plasma cells. Based on the participants' age, medical history, and indicators of good general health, the participants in the GRIFFIN study were also eligible to receive autologous stem cell transplant as part of their therapy. This summary describes results for the Black participants of the GRIFFIN clinical study who received daratumumab plus RVd therapy (called D-RVd) to see if D-RVd therapy is better than RVd therapy at reducing the amount of multiple myeloma cancer cells in a patient's body. Why did the researchers evaluate the results for Black patients in the GRIFFIN study? Due to racial disparities leading to historically low representation of minority groups in clinical studies, optimal treatments are not defined for Black patients with newly diagnosed multiple myeloma. Since previously published results from the overall population in the GRIFFIN study indicated that D-RVd therapy was better than RVd therapy, the researchers wanted to determine if this was also the case among Black participants. What were the results? Out of 207 participants in the GRIFFIN study, 15% (32 participants) were Black and 78% (161 participants) were White. In both Black and White participants, D-RVd therapy reduced the amount of myeloma cancer cells more than RVd therapy. Additionally, D-RVd and RVd therapy had similar safety results for Black and White participants. What do the results mean? This analysis of GRIFFIN by race shows that Black people benefit from the daratumumab-containing D-RVd therapy as much as White people. Additionally, D-RVd therapy had similar safety results to RVd therapy for both Black and White people. Clinical Trial Registration: NCT02874742 ( ClinicalTrials.gov )

Abstract: Introduction: DARA is approved for NDMM and previously treated MM. In the primary analysis of the phase 2 GRIFFIN trial (NCT02874742) in autologous stem cell transplant (ASCT)-eligible NDMM pts (median follow-up, 13.5 mo), DARA plus RVd (D-RVd) improved the rate of stringent complete response (sCR) by the end of post-ASCT consolidation versus RVd (42.4% vs 32.0%, 1-sided P=0.068) (Voorhees PM, et al. Blood. 2020). With longer follow-up (median, 27.4 mo), responses deepened and were improved for D-RVd versus RVd (sCR rate: 63.6% vs 47.4%, 2-sided P=0.0253), as did the MRD-negativity (10 -5) rate (62.5% vs 27.2%, P & lt;0.0001) (Kaufman JL, et al. Blood. 2020). Here, we present updated efficacy and safety results after 24 months of maintenance therapy or treatment discontinuation (median follow-up, 38.6 mo). Methods: Pts with NDMM eligible for high-dose therapy (HDT) and ASCT were randomized 1:1 to receive RVd or D-RVd, stratified by ISS disease stage (I, II, or III) and creatinine clearance (30-50 or & gt;50 mL/min). Pts received 4 RVd or D-RVd induction cycles, HDT, ASCT, 2 RVd or D-RVd consolidation cycles, and maintenance with lenalidomide (R) alone or with DARA (D-R) for 24 months. During induction and consolidation (21-day cycles), pts received R (25 mg PO on Days 1-14), bortezomib (1.3 mg/m 2 SC on Days 1, 4, 8, and 11), and dexamethasone (40 mg PO QW) ± DARA (16 mg/kg IV on Days 1, 8, and 15 of Cycles 1-4 and Day 1 of Cycles 5-6). During maintenance (Cycles 7-32; 28-day cycles), pts received R (10 mg PO on Days 1-21; if tolerated, 15 mg in Cycle 10+) ± DARA (16 mg/kg IV) Q8W (or Q4W per pt decision after protocol amendment 2) until disease progression or up to 24 months. The primary endpoint was sCR rate by the end of post-ASCT consolidation (tested at 1-sided α of 0.10). Responses were assessed per IMWG criteria by a validated computer algorithm. Key secondary endpoints included progression-free survival (PFS) and MRD negativity assessed by NGS at the minimum sensitivity threshold of 10 -5, at suspected complete response or better (≥CR), at the end of induction and consolidation, and after 12 and 24 months of maintenance, regardless of response. Secondary analyses were evaluated using 2-sided α of 0.05, not adjusted for multiplicity. Results: In total, 207 pts were randomized (D-RVd, n=104; RVd, n=103); baseline characteristics were well balanced. After 24 months of D-R or R maintenance therapy, the rate of sCR favored D-RVd versus RVd in the response-evaluable population (66.0% [66/100] vs 47.4% [46/97] , 2-sided P=0.0096; Figure). In the intent-to-treat (ITT) population, MRD-negativity (10 -5) rates also remained higher for D-RVd versus RVd (64.4% [67/104] vs 30.1% [31/103] , P & lt;0.0001), as well as among pts who achieved ≥CR (78.0% [64/82] vs 47.5% [28/59] , P=0.0003). Similarly, MRD-negativity (10 -6) rates favored D-RVd versus RVd in the ITT population (35.6% vs 14.6%, P=0.0007; Figure), as well as among pts who achieved ≥CR (42.7% vs 22.0%, P=0.0121). The rate of sustained MRD negativity (10 -5) lasting ≥12 months in the ITT population was & gt;3-fold higher for D-RVd versus RVd (44.2% vs 12.6%, P & lt;0.0001). With 38.6 months follow-up, median PFS was not reached in either arm but trended towards favoring D-RVd versus RVd (hazard ratio, 0.46; 95% CI, 0.21-1.01; Figure). The estimated 36-month PFS rate was 88.9% for D-RVd and 81.2% for RVd. In total, 14 pts died (D-RVd, n=7; RVd, n=7), 9 from progressive disease (D-RVd, n=5; RVd, n=4). No new safety concerns were observed with extended follow-up. In total, 86.9% (86/99) of D-RVd pts and 79.4% (81/102) of RVd pts developed grade 3/4 treatment-emergent adverse events (TEAEs). Serious TEAEs occurred in 46.5% of D-RVd pts and 52.0% of RVd pts. TEAEs led to discontinuation of study treatment at the same rate (D-RVd, 34.3%; RVd, 34.3%). One pt in each group died due to TEAEs, neither related to study treatment. Conclusion: After 24 months of maintenance therapy, the addition of DARA to RVd induction and consolidation in conjunction with ASCT, followed by DARA plus R maintenance, continued to demonstrate deep and durable responses in pts with transplant-eligible NDMM, including sCR and MRD-negativity (10 -5 and 10 -6) rates. While this study was not powered for PFS, there is a positive trend towards improved PFS in the D-RVd group. No new safety concerns were observed with longer follow-up. These results support the use of D-RVd induction/consolidation and D-R maintenance in transplant-eligible NDMM pts. Figure 1 Figure 1. Disclosures Kaufman: Sutro, Takeda: Research Funding; Incyte, TG Therapeutics: Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Research Funding; Amgen: Research Funding; Tecnofarma SAS, AbbVie: Honoraria; Janssen: Honoraria; Fortis Therapeutics: Research Funding; Novartis: Research Funding; Incyte, celgene: Consultancy; Heidelberg Pharma: Research Funding; Roche/Genetech, Tecnopharma: Consultancy, Honoraria; Genentech, AbbVie, Janssen: Consultancy, Research Funding. Sborov: Sanofi: Consultancy; SkylineDx: Consultancy; GlaxoSmithKline: Consultancy; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees. Reeves: Bristol-Myers Squibb: Speakers Bureau; Incyte Corporation: Honoraria; Takeda: Honoraria; Pharma Essentia: Consultancy, Honoraria. Rodriguez: Janssen: Consultancy, Speakers Bureau; BMS: Consultancy, Speakers Bureau; Karyopharm: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Oncopeptides: Consultancy, Honoraria. Chari: Oncopeptides: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy, Membership on an entity's Board of Directors or advisory committees; Shattuck Labs: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Research Funding; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Secura Bio: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi Genzyme: Consultancy, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Research Funding; Antengene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Millenium/Takeda: Consultancy, Research Funding; Janssen Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmacyclics: Research Funding; BMS/Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Silbermann: Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Sanofi Genzyme: Membership on an entity's Board of Directors or advisory committees, Research Funding. Costa: Pfizer: Consultancy, Honoraria; Karyopharm: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau. Anderson: Celgene, BMS, Janssen, GSK, Karyopharm, Oncopeptides, Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Shah: GSK: Consultancy; Nektar: Research Funding; Kite: Consultancy; CareDx: Consultancy; CSL Behring: Consultancy; Indapta Therapeutics: Consultancy; Janssen: Research Funding; Poseida: Research Funding; Karyopharm: Consultancy; BMS/Celgene: Research Funding; Bluebird Bio: Research Funding; Oncopeptides: Consultancy; Teneobio: Research Funding; Sanofi: Consultancy; Precision Biosciences: Research Funding; Sutro Biopharma: Research Funding; Amgen: Consultancy. Bumma: Janssen: Membership on an entity's Board of Directors or advisory committees; Amgen: Speakers Bureau; Sanofi: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Holstein: Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Genentech, GSK, Janssen, Secura Bio, Sorrento: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Membership on an entity's Board of Directors or advisory committees, Research Funding. Jakubowiak: Abbvie: Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Gracell: Membership on an entity's Board of Directors or advisory committees. Wildes: Carevive: Consultancy; Seattle Genetics: Consultancy; Sanofi: Consultancy; Janssen: Consultancy. Orlowski: Asylia Therapeutics, Inc., BioTheryX, Inc., and Heidelberg Pharma, AG.: Other: Laboratory research funding; CARsgen Therapeutics, Celgene, Exelixis, Janssen Biotech, Sanofi-Aventis, Takeda Pharmaceuticals North America, Inc.: Other: Clinical research funding; Asylia Therapeutics, Inc.: Current holder of individual stocks in a privately-held company, Patents & Royalties; Amgen, Inc., BioTheryX, Inc., Bristol-Myers Squibb, Celgene, Forma Therapeutics, Genzyme, GSK Biologicals, Janssen Biotech, Juno Therapeutics, Karyopharm Therapeutics, Inc., Kite Pharma, Neoleukin Corporation, Oncopeptides AB, Regeneron Pharmaceuticals, I: Membership on an entity's Board of Directors or advisory committees; Amgen, Inc., BioTheryX, Inc., Bristol-Myers Squibb, Celgene, EcoR1 Capital LLC, Genzyme, GSK Biologicals, Janssen Biotech, Karyopharm Therapeutics, Inc., Neoleukin Corporation, Oncopeptides AB, Regeneron Pharmaceuticals, Inc., Sanofi-Aventis, and Takeda P: Consultancy, Honoraria. Shain: AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen Inc: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi Genzyme: Consultancy, Speakers Bureau; GlaxoSmithLine, LLC: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Adaptive Biotechnologies Corporation: Consultancy, Speakers Bureau; Janssen oncology: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Karyopharm Therapeutics Inc.: Honoraria, Research Funding; Novartis Pharmaceuticals Corporation: Consultancy. Cowan: BMS: Research Funding; Secura Bio: Consultancy; GSK: Consultancy; Harpoon: Research Funding; Cellectar: Consultancy; Sanofi: Consultancy, Research Funding; AbbVie: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Nektar: Research Funding. Pei: Janssen: Current Employment, Current equity holder in publicly-traded company. Cortoos: Janssen: Current Employment, Current equity holder in publicly-traded company. Patel: Janssen: Current Employment. Bartlett: Janssen: Current Employment. Vermeulen: Janssen: Current Employment, Current equity holder in publicly-traded company. Lin: Janssen: Current Employment. Richardson: Sanofi: Consultancy; Secura Bio: Consultancy; Regeneron: Consultancy; Karyopharm: Consultancy, Research Funding; Janssen: Consultancy; Protocol Intelligence: Consultancy; Celgene/BMS: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; GlaxoSmithKline: Consultancy; AstraZeneca: Consultancy; Oncopeptides: Consultancy, Research Funding; AbbVie: Consultancy; Jazz Pharmaceuticals: Consultancy, Research Funding. Voorhees: Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: The specific regimen combination is not yet approved, but individual components are.

Abstract: Introduction: Daratumumab (DARA) is approved across lines of therapy for multiple myeloma. In the primary analysis of the phase 2 GRIFFIN trial (NCT02874742) in pts with transplant-eligible NDMM (median follow-up, 13.5 mo), D-RVd improved the rate of stringent complete response (sCR) by the end of post-autologous stem cell transplant (ASCT) consolidation versus RVd (42.4% vs 32.0%; odds ratio [OR], 1.57; 95% CI, 0.87-2.82; 1-sided P=0.068) (Voorhees PM, et al. Blood. 2020). With longer follow-up (median, 27.4 mo) after 12 months of maintenance therapy, sCR rates deepened for D-RVd versus RVd (63.6% vs 47.4%, 2-sided P=0.0253), as did the rate of minimal residual disease (MRD; 10 -5) negativity (62.5% vs 27.2%, P & lt;0.0001) (Kaufman JL, et al. Blood. 2020). Here, we present an analysis among clinically relevant subgroups (age ≥65 years, International Staging System [ISS] stage III disease, and high cytogenetic risk [del17p, t(4;14), or t(14;16) abnormalities] ) after 24 months of maintenance therapy (median follow-up, 38.6 mo). Methods: Eligible pts with transplant-eligible NDMM were randomized 1:1 to D-RVd or RVd. Pts received 4 RVd or D-RVd induction cycles, high dose therapy, ASCT, 2 RVd or D-RVd consolidation cycles, and maintenance with lenalidomide (R) alone or with DARA (D-R) for 24 months. During induction and consolidation (21-day cycles), pts received R (25 mg PO on Days 1-14), bortezomib (1.3 mg/m 2 SC on Days 1, 4, 8, and 11), and dexamethasone (40 mg PO QW) ± DARA (16 mg/kg IV on Days 1, 8, and 15 of Cycles 1-4 and Day 1 of Cycles 5-6). During maintenance (Cycles 7-32; 28-day cycles), pts received R (10 mg PO on Days 1-21; if tolerated, 15 mg in Cycles 10+) ± DARA (16 mg/kg IV Q8W, or Q4W per pt decision after Amendment 2) until disease progression or up to 24 months. The primary endpoint was sCR rate by the end of post-ASCT consolidation. Responses were assessed per International Myeloma Working Group criteria by a validated computer algorithm. Additional endpoints included progression-free survival (PFS) and MRD-negativity (10 -5) rate by next-generation sequencing. Results: In total, 207 pts were randomized (D-RVd, n=104; RVd, n=103); each group had a similar number of pts with age ≥65 years (n=28; n=28), ISS stage III disease (n=14; n=14), or high cytogenetic risk (n=16; n=14). Among response-evaluable pts, the rate of sCR after 24 months of maintenance therapy was numerically higher for D-RVd versus RVd among pts ≥65 years (63.0% vs 40.7%, OR, 2.47, 95% CI, 0.83-7.39), but similar for D-RVd and RVd pts with ISS stage III disease (57.1% vs 61.5%, OR, 0.83, 95% CI, 0.18-3.88) and high cytogenetic risk (43.8% vs 38.5%, OR, 1.24, 95% CI, 0.28-5.53; Figure). MRD-negativity (10 -5) rates favored D-RVd versus RVd across all subgroups: ≥65 years (67.9% vs 17.9%), ISS stage III disease (71.4% vs 35.7%), and high cytogenetic risk (43.8% vs 28.6%; Figure). With 38.6 months median follow-up, median PFS was not reached (NR) for pts ≥65 years in either treatment group (6 pts progressed: D-RVd, n=1; RVd, n=5). Among pts with ISS stage III disease, median PFS was NR for D-RVd and 33.1 months for RVd (7 pts progressed: D-RVd, n=1; RVd, n=6). Among pts with high cytogenetic risk, median PFS was NR for D-RVd and 36.1 months for RVd (10 pts progressed: D-RVd, n=5; RVd, n=5; Figure). In pts ≥65 years, grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 88.9% of D-RVd pts and 77.8% of RVd pts; the most common (≥20%) were neutropenia (37.0%; 29.6%) and lymphopenia (25.9%; 11.1%). Serious TEAEs occurred in 55.6% and 40.7% of pts, respectively. TEAEs led to study treatment discontinuation in 33.3% of D-RVd pts and 25.9% of RVd pts. One death due to a TEAE (unrelated to study treatment) occurred in a D-RVd pt ≥65 years of age. Conclusion: Subgroup analyses of pts in GRIFFIN show that the addition of DARA to RVd induction/consolidation and R maintenance, in conjunction with ASCT, may benefit clinically relevant subgroups. sCR rates were improved for D-RVd versus RVd in pts ≥65 years but not in pts with ISS stage III disease or high cytogenetic risk. Improved MRD-negativity rates were observed for D-RVd in all subgroups. Although immature and with limited pt numbers, PFS results also trended towards favoring D-RVd in these subgroups. Among pts ≥65 years, TEAEs and serious TEAEs were numerically higher for D-RVd. These results support the use of DARA in transplant-eligible NDMM pts among high-risk subgroups, although larger studies are needed. Figure 1 Figure 1. Disclosures Anderson: Celgene, BMS, Janssen, GSK, Karyopharm, Oncopeptides, Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Kaufman: Sutro, Takeda: Research Funding; Roche/Genetech, Tecnopharma: Consultancy, Honoraria; Janssen: Honoraria; Novartis: Research Funding; Heidelberg Pharma: Research Funding; Incyte, celgene: Consultancy; BMS: Consultancy, Research Funding; Amgen: Research Funding; Tecnofarma SAS, AbbVie: Honoraria; Fortis Therapeutics: Research Funding; Incyte, TG Therapeutics: Membership on an entity's Board of Directors or advisory committees; Genentech, AbbVie, Janssen: Consultancy, Research Funding. Sborov: Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy; SkylineDx: Consultancy; Sanofi: Consultancy. Reeves: Pharma Essentia: Consultancy, Honoraria; Takeda: Honoraria; Bristol-Myers Squibb: Speakers Bureau; Incyte Corporation: Honoraria. Rodriguez: Takeda: Consultancy, Speakers Bureau; Oncopeptides: Consultancy, Honoraria; Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Karyopharm: Consultancy, Speakers Bureau; BMS: Consultancy, Speakers Bureau. Chari: Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Shattuck Labs: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Secura Bio: Consultancy, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Research Funding; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Millenium/Takeda: Consultancy, Research Funding; BMS/Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Antengene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi Genzyme: Consultancy, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Membership on an entity's Board of Directors or advisory committees. Silbermann: Sanofi Genzyme: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Costa: Karyopharm: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; BMS: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding. Shah: Janssen: Research Funding; Nektar: Research Funding; Kite: Consultancy; Karyopharm: Consultancy; Indapta Therapeutics: Consultancy; Bluebird Bio: Research Funding; BMS/Celgene: Research Funding; Amgen: Consultancy; CareDx: Consultancy; Poseida: Research Funding; Precision Biosciences: Research Funding; Oncopeptides: Consultancy; CSL Behring: Consultancy; GSK: Consultancy; Sanofi: Consultancy; Sutro Biopharma: Research Funding; Teneobio: Research Funding. Bumma: Janssen: Membership on an entity's Board of Directors or advisory committees; Amgen: Speakers Bureau; Sanofi: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Holstein: Oncopeptides: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Genentech, GSK, Janssen, Secura Bio, Sorrento: Honoraria; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Jakubowiak: Celgene: Membership on an entity's Board of Directors or advisory committees; Gracell: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees. Wildes: Carevive: Consultancy; Seattle Genetics: Consultancy; Sanofi: Consultancy; Janssen: Consultancy. Orlowski: Amgen, Inc., BioTheryX, Inc., Bristol-Myers Squibb, Celgene, EcoR1 Capital LLC, Genzyme, GSK Biologicals, Janssen Biotech, Karyopharm Therapeutics, Inc., Neoleukin Corporation, Oncopeptides AB, Regeneron Pharmaceuticals, Inc., Sanofi-Aventis, and Takeda P: Consultancy, Honoraria; Asylia Therapeutics, Inc., BioTheryX, Inc., and Heidelberg Pharma, AG.: Other: Laboratory research funding; CARsgen Therapeutics, Celgene, Exelixis, Janssen Biotech, Sanofi-Aventis, Takeda Pharmaceuticals North America, Inc.: Other: Clinical research funding; Asylia Therapeutics, Inc.: Current holder of individual stocks in a privately-held company, Patents & Royalties; Amgen, Inc., BioTheryX, Inc., Bristol-Myers Squibb, Celgene, Forma Therapeutics, Genzyme, GSK Biologicals, Janssen Biotech, Juno Therapeutics, Karyopharm Therapeutics, Inc., Kite Pharma, Neoleukin Corporation, Oncopeptides AB, Regeneron Pharmaceuticals, I: Membership on an entity's Board of Directors or advisory committees. Shain: Sanofi Genzyme: Consultancy, Speakers Bureau; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive Biotechnologies Corporation: Consultancy, Speakers Bureau; Novartis Pharmaceuticals Corporation: Consultancy; GlaxoSmithLine, LLC: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Karyopharm Therapeutics Inc.: Honoraria, Research Funding; Amgen Inc: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen oncology: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Cowan: BMS: Research Funding; Secura Bio: Consultancy; GSK: Consultancy; Harpoon: Research Funding; Cellectar: Consultancy; Sanofi: Consultancy, Research Funding; AbbVie: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Nektar: Research Funding. Pei: Janssen: Current Employment, Current equity holder in publicly-traded company. Cortoos: Janssen: Current Employment, Current equity holder in publicly-traded company. Patel: Janssen: Current Employment. Bartlett: Janssen: Current Employment. Vermeulen: Janssen: Current Employment, Current equity holder in publicly-traded company. Lin: Janssen: Current Employment. Voorhees: Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Richardson: AbbVie: Consultancy; Oncopeptides: Consultancy, Research Funding; Celgene/BMS: Consultancy, Research Funding; Regeneron: Consultancy; AstraZeneca: Consultancy; Secura Bio: Consultancy; Janssen: Consultancy; Protocol Intelligence: Consultancy; Karyopharm: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; GlaxoSmithKline: Consultancy; Sanofi: Consultancy; Jazz Pharmaceuticals: Consultancy, Research Funding. OffLabel Disclosure: The specific regimen combination is not yet approved, but individual components are.

Abstract: In the phase 2 GRIFFIN trial ( ClinicalTrials.gov identifier: NCT02874742), daratumumab added to lenalidomide, bortezomib, and dexamethasone (D‐RVd) improved depth of response and progression‐free survival (PFS) versus lenalidomide, bortezomib, and dexamethasone (RVd) alone in transplant‐eligible (TE) patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient‐reported outcomes (PROs) collected using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30‐item (QLQ‐C30), EORTC Quality of Life Questionnaire Multiple Myeloma Module 20‐item (QLQ‐MY20), and EuroQol 5‐Dimension 5‐Level (EQ‐5D‐5L) tools on day 1 of cycles 1, 2, and 3; on day 21 of cycle 4 (end of induction therapy); on day 1 of cycle 5; on day 21 of cycle 6 (end of posttransplant consolidation therapy); and at months 6, 12, 18, and 24 of maintenance therapy. Meaningful improvements from baseline were seen in most of the PRO scales with both treatments after consolidation and were sustained for at least 2 years of maintenance treatment. Large reductions from baseline (~20 points) were especially observed in pain symptoms for both treatment groups, although these were numerically higher for patients receiving D‐RVd during the majority of the time points. In addition, improvements in key scales, such as global health status, fatigue symptoms, and physical functioning, were also seen with both D‐RVd and RVd. These improvements in health‐related quality of life contribute to the totality of evidence supporting the improvement in clinical outcomes such as response rates and PFS with D‐RVd in induction, consolidation, and maintenance therapy in TE patients with NDMM.