Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk
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Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk. / Weisel, Katja; Spencer, Andrew; Lentzsch, Suzanne; Avet-Loiseau, Hervé; Mark, Tomer M; Spicka, Ivan; Masszi, Tamas; Lauri, Birgitta; Levin, Mark-David; Bosi, Alberto; Hungria, Vania; Cavo, Michele; Lee, Je-Jung; Nooka, Ajay; Quach, Hang; Munder, Markus; Lee, Cindy; Barreto, Wolney; Corradini, Paolo; Min, Chang-Ki; Chanan-Khan, Asher A; Horvath, Noemi; Capra, Marcelo; Beksac, Meral; Ovilla, Roberto; Jo, Jae-Cheol; Shin, Ho-Jin; Sonneveld, Pieter; Casneuf, Tineke; DeAngelis, Nikki; Amin, Himal; Ukropec, Jon; Kobos, Rachel; Mateos, Maria-Victoria.
In: J HEMATOL ONCOL, Vol. 13, No. 1, 20.08.2020, p. 115.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk
AU - Weisel, Katja
AU - Spencer, Andrew
AU - Lentzsch, Suzanne
AU - Avet-Loiseau, Hervé
AU - Mark, Tomer M
AU - Spicka, Ivan
AU - Masszi, Tamas
AU - Lauri, Birgitta
AU - Levin, Mark-David
AU - Bosi, Alberto
AU - Hungria, Vania
AU - Cavo, Michele
AU - Lee, Je-Jung
AU - Nooka, Ajay
AU - Quach, Hang
AU - Munder, Markus
AU - Lee, Cindy
AU - Barreto, Wolney
AU - Corradini, Paolo
AU - Min, Chang-Ki
AU - Chanan-Khan, Asher A
AU - Horvath, Noemi
AU - Capra, Marcelo
AU - Beksac, Meral
AU - Ovilla, Roberto
AU - Jo, Jae-Cheol
AU - Shin, Ho-Jin
AU - Sonneveld, Pieter
AU - Casneuf, Tineke
AU - DeAngelis, Nikki
AU - Amin, Himal
AU - Ukropec, Jon
AU - Kobos, Rachel
AU - Mateos, Maria-Victoria
PY - 2020/8/20
Y1 - 2020/8/20
N2 - BACKGROUND: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM).METHODS: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk.RESULTS: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR.CONCLUSION: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.
AB - BACKGROUND: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM).METHODS: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk.RESULTS: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR.CONCLUSION: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.
U2 - 10.1186/s13045-020-00948-5
DO - 10.1186/s13045-020-00948-5
M3 - SCORING: Journal article
C2 - 32819447
VL - 13
SP - 115
JO - J HEMATOL ONCOL
JF - J HEMATOL ONCOL
SN - 1756-8722
IS - 1
ER -