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CI 67.0 to 97.5 ) among patients treated with VenDd and 66.7 % ( 95 % CI 42.5 to 82.5 ) in the VenDVd group . DOR was not reached in either arm , but the estimated 18-month DOR was 90.5 % ( 95 % CI 67.0 to 97.5 ) for patients treated with VenDd and 70 % ( 95 % CI 45.1 to 85.3 ) with VenDVd . Among patients treated with VenDd , 33 % achieved an MRD-negative response (< 10 -5 ), compared with 21 % who received VenDVd ( see FIGURE B at right ).
Five out of six patients ( 83 %) in the VenDVd group who had t ( 11 ; 14 ) relapsed or refractory MM experienced a response , compared with 94 % ( n = 17 ) of the 18 patients who did not have t ( 11 ; 14 ). All four patients with high-risk cytogenetics in the VenDVd arm and one patient with high-risk cytogenetics in the VenDd arm had a response .
Median time on study was 20.9 months ( range = 19.2-30 ) with VenDd and 20.4 months ( range = 6.3- 25.7 ) with VenDVd .
Common adverse events ( AEs ) reported in patients treated with VenDd and VenDVd included diarrhea ( 63 % and 54 %, respectively ) and nausea ( 50 % and 50 %). Grade ≥3 AEs were reported in 88 % of patients who received VenDd and 71 % of patients who received VenDVd .
Eight patients in the VenDd group ( 33 %) and six patients in the VenDVd group ( 25 %) had venetoclax dose reductions because of AEs . In the VenDd group , six patients discontinued treatment with venetoclax because of melanoma ( n = 1 ), withdrawn consent ( n = 2 ), progressive disease ( n = 2 ), and opting for autologous transplantation ( n = 1 ). In the VenDVd group ,
FIGURE . Response Rates and MRD Negativity Rates in Patients Treated With VenDd and VenDVd
( A ) Response rates and ( B ) MRD negativity rates in patients treated with VenDd in part 1 and those treated with VenDVd in part 2 . The 95 % CIs for response rates in part 1 were 78.9 to 99.9 for ORR , 36.6 to 77.9 for ≥ CR , and 78.9 to 99.9 for ≥ VGPR . The 95 % CIs for response rates in part 2 were 73.0 to 99.0 for ORR , 25.6 to 67.2 for ≥ CR , and 57.8 to 92.9 for ≥ VGPR . CR , complete response ; PR , partial response ; sCR , stringent complete response .
12 patients discontinued venetoclax because of AEs ( n = 3 ), withdrawn consent ( n = 2 ), and progressive disease ( n = 7 ).
One patient in the VenDVd group died from sepsis while in hospice care three weeks after discontinuing treatment because of disease progression .
“ Although differences in the study population and treatment schedule between the VenDd and VenDVd arms prevent direct comparisons of the two arms , neither combination had new safety signals , and the addition of daratumumab to venetoclax 800 mg day did not appear to alter the known safety profiles of venetoclax or daratumumab combinations ,” the authors wrote .
The authors report relationships with AbbVie , which sponsored the study .
Reference Bahlis NJ , Baz R , Harrison SJ , et al . Phase I study of venetoclax plus daratumumab and dexamethasone , with or without bortezomib , in patients with relapsed or refractory multiple myeloma with and without t ( 11 ; 14 ) [ published online ahead of print , 2021 Aug 13 ]. J Clin Oncol . doi : 10.1200 / JCO . 21.00443 .
Patient-Reported Outcome Questionnaire Shows Promise for Monitoring ITP
A draft version of a 10-item patient-reported outcome ( PRO ) questionnaire has been developed to evaluate the impact of immune thrombocytopenia ( ITP ) on patients and assist in shared decision-making between patients and physicians . Results from a recent study led by Nichola Cooper , MD , of Imperial College London in the U . K ., confirmed the content validity of the ITP Life Quality Index ( ILQI ). These findings also suggest the concepts assessed using the PRO are relative to and understood by most patients with ITP .
Dr . Cooper and colleagues conducted a qualitative telephone interview with 15 adult patients with ITP . The interview , which featured concept elicitation and cognitive debriefing portions , explored ITP symptoms and the impact these symptoms had on patients and sought to confirm the ILQI content validity .
The concept elicitation phase focused on broad , open-ended questions to gain information on ITP symptoms , the impacts of these symptoms , and the treatments used for ITP . Focused questions followed to investigate other concepts , including the impact ITP had on patients ’ emotional well-being and social lives .
Additionally , the cognitive debriefing phase of the interview asked patients to complete the ILQI using a “ think-aloud ” exercise , in which they speak aloud their thoughts while reading the questionnaire ’ s
instructions and select a response for each item . Researchers asked patients detailed questions about their understanding and the relevance of each ILQI item , instruction , and answer options . Patient feedback on the draft ’ s wording and suggestions for alternative terminology were also requested .
The mean age of patients interviewed was 51.3 years , and the majority were white ( n = 14 ) and female ( n = 10 ). An ITP diagnosis was made at a mean age of 40.9 years , with a mean disease duration of 10 years . Nine patients reported that it took several months after presentation to be diagnosed with ITP .
During the concept elicitation phase , the participants reported 13 symptom concepts , including bruising ( 100 %), fatigue ( 93.3 %), and bleeding from gums / blood blisters ( 86.7 %). Several impacts of ITP were also reported by patients , including decreased or complete lack of ability to participate in sports ( 100 %), anxiety ( 80 %), and the need to avoid non-sporting activities ( 73.3 %).
In the cognitive debriefing phase , all patients said they understood the ILQI instructions . The researchers noted that the clear instructions enabled patients to complete the ILQI independently .
While the draft ILQI featured a one-week recall period , 86.7 % of participants said this period was not appropriate , given that the patients ’ experiences with
ITP did not change weekly , nor were the activities listed in the PRO measure consistently practiced each week . Therefore , the researchers increased the recall period for the ILQI to “ the past month .”
More than half of patients with ITP ( 66.7 %) said the draft response options were appropriate , but 33.5 % suggested changes to response options . These changes , as suggested by participants , included changing to a 0 to 10 numeric rating scale for each item , changing “ more than half the time ” to “ half the time ,” and eliminating “ more than half the time .”
Limitations of this study included the small sample size as well as the inclusion of mostly white participants from the U . K . As a result , these findings may not be generalizable to the wider ITP population .
Despite these limitations , “[ we hope ] that cross-cultural implementation of the ILQI will lead to more consistency of treatment in clinical practice and better outcomes for patients with ITP ,” the authors wrote . ●
Researchers reported relationships with Novartis , which funded the study .
Reference Cooper N , Cuker A , Bonner N , et al . Qualitative study to support the content validity of the immune thrombocytopenia ( ITP ) Life Quality Index ( ILQI ). Br J Haematol . 2021 ; 194:759- 766 .
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