Abstract
Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment. Patients received daratumumab 16 mg/kg at the recommended dosing schedule, pomalidomide 4 mg daily for 21 days of each 28-day cycle, and dexamethasone 40 mg weekly. Safety was the primary end point. Overall response rate (ORR) and minimal residual disease (MRD) by next-generation sequencing were secondary end points. Patients (N 5 103) received a median (range) of 4 (1-13) prior therapies; 76% received ≥3 prior therapies. The safety profile of daratumumab plus pomdex was similar to that of pom-dex alone, with the exception of daratumumab-specific infusion-related reactions (50%) and a higher incidence of neutropenia, although without an increase in infection rate. Common grade ≥3 adverse events were neutropenia (78%), anemia (28%), and leukopenia (24%). ORR was 60% and was generally consistent across subgroups (58% in double-refractory patients).Amongpatients with a complete response or better, 29% were MRD negative at a threshold of 1025. Among the 62 responders, median duration of response was not estimable (NE; 95% confidence interval [CI], 13.6-NE). At a median follow-up of 13.1 months, the median progression-free survival was 8.8 (95% CI, 4.6-15.4) months andmedian overall survivalwas17.5 (95% CI, 13.3-NE) months.The estimated 12-month survival ratewas 66% (95% CI, 55.6-74.8). Aside from increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the individual therapies. Deep, durable responses were observed in heavily treated patients.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 974-981 |
| Number of pages | 8 |
| Journal | Blood |
| Volume | 130 |
| Issue number | 8 |
| DOIs | |
| State | Published - Aug 24 2017 |
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ASJC Scopus subject areas
- Immunology
- Biochemistry
- Hematology
- Cell Biology
Cite this
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. / Chari, Ajai; Suvannasankha, Attaya; Fay, Joseph W.; Arnulf, Bertrand; Kaufman, Jonathan L.; Ifthikharuddin, Jainulabdeen J.; Weiss, Brendan M.; Krishnan, Amrita; Lentzsch, Suzanne; Comenzo, Raymond; Wang, Jianping; Nottage, Kerri; Chiu, Christopher; Khokhar, Nushmia Z.; Ahmadi, Tahamtan; Lonial, Sagar.
In: Blood, Vol. 130, No. 8, 24.08.2017, p. 974-981.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
AU - Chari, Ajai
AU - Suvannasankha, Attaya
AU - Fay, Joseph W.
AU - Arnulf, Bertrand
AU - Kaufman, Jonathan L.
AU - Ifthikharuddin, Jainulabdeen J.
AU - Weiss, Brendan M.
AU - Krishnan, Amrita
AU - Lentzsch, Suzanne
AU - Comenzo, Raymond
AU - Wang, Jianping
AU - Nottage, Kerri
AU - Chiu, Christopher
AU - Khokhar, Nushmia Z.
AU - Ahmadi, Tahamtan
AU - Lonial, Sagar
PY - 2017/8/24
Y1 - 2017/8/24
N2 - Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment. Patients received daratumumab 16 mg/kg at the recommended dosing schedule, pomalidomide 4 mg daily for 21 days of each 28-day cycle, and dexamethasone 40 mg weekly. Safety was the primary end point. Overall response rate (ORR) and minimal residual disease (MRD) by next-generation sequencing were secondary end points. Patients (N 5 103) received a median (range) of 4 (1-13) prior therapies; 76% received ≥3 prior therapies. The safety profile of daratumumab plus pomdex was similar to that of pom-dex alone, with the exception of daratumumab-specific infusion-related reactions (50%) and a higher incidence of neutropenia, although without an increase in infection rate. Common grade ≥3 adverse events were neutropenia (78%), anemia (28%), and leukopenia (24%). ORR was 60% and was generally consistent across subgroups (58% in double-refractory patients).Amongpatients with a complete response or better, 29% were MRD negative at a threshold of 1025. Among the 62 responders, median duration of response was not estimable (NE; 95% confidence interval [CI], 13.6-NE). At a median follow-up of 13.1 months, the median progression-free survival was 8.8 (95% CI, 4.6-15.4) months andmedian overall survivalwas17.5 (95% CI, 13.3-NE) months.The estimated 12-month survival ratewas 66% (95% CI, 55.6-74.8). Aside from increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the individual therapies. Deep, durable responses were observed in heavily treated patients.
AB - Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment. Patients received daratumumab 16 mg/kg at the recommended dosing schedule, pomalidomide 4 mg daily for 21 days of each 28-day cycle, and dexamethasone 40 mg weekly. Safety was the primary end point. Overall response rate (ORR) and minimal residual disease (MRD) by next-generation sequencing were secondary end points. Patients (N 5 103) received a median (range) of 4 (1-13) prior therapies; 76% received ≥3 prior therapies. The safety profile of daratumumab plus pomdex was similar to that of pom-dex alone, with the exception of daratumumab-specific infusion-related reactions (50%) and a higher incidence of neutropenia, although without an increase in infection rate. Common grade ≥3 adverse events were neutropenia (78%), anemia (28%), and leukopenia (24%). ORR was 60% and was generally consistent across subgroups (58% in double-refractory patients).Amongpatients with a complete response or better, 29% were MRD negative at a threshold of 1025. Among the 62 responders, median duration of response was not estimable (NE; 95% confidence interval [CI], 13.6-NE). At a median follow-up of 13.1 months, the median progression-free survival was 8.8 (95% CI, 4.6-15.4) months andmedian overall survivalwas17.5 (95% CI, 13.3-NE) months.The estimated 12-month survival ratewas 66% (95% CI, 55.6-74.8). Aside from increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the individual therapies. Deep, durable responses were observed in heavily treated patients.
UR - http://www.scopus.com/inward/record.url?scp=85028453660&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85028453660&partnerID=8YFLogxK
U2 - 10.1182/blood-2017-05-785246
DO - 10.1182/blood-2017-05-785246
M3 - Article
C2 - 28637662
AN - SCOPUS:85028453660
VL - 130
SP - 974
EP - 981
JO - Blood
JF - Blood
SN - 0006-4971
IS - 8
ER -