Selinexor, Bortezomib and Dexamethasone: An Effective Salvage Regimen for Heavily Pretreated Myeloma Patients

Figures & data

Table 1 Demographics and Clinical Parameters (N=7)

Characteristic
Median Age at start of treatment with selinexor, y (range)	56 (39–68)
Gender
Male	5 (71.4)
Female	2 (29.0)
Type of MM
IgG lambda	2 (29.0)
IgA kappa/lambda	4 (57.1)
Kappa/lambda light chain	1 (14.3)
Cytogenetic abnormalities by FISH
t(11;14)	1 (14.3)
Trisomy 1q	1 (14.3)
Amp(1q21); t(14;20)(q32;q11); loss of 16q23	1 (14.3)
Del(13q14); amp(1q21); t(11;14)	1 (14.3)
Unknown	3 (42.8)
R-ISS
I	1 (14.3)
II	2 (29.0)
III	2 (29.0)
Unknown	2 (29.0)
Prior lines of therapy
4–8	4 (57.1)
9–12	3 (42.8)
Median no. of prior lines of therapy (range)	8 (4–12)
Prior belantamab	3 (42.8)
Prior CART Therapy	2 (29.0)
Refractory status of disease
Pomalidomide	7 (100.0)
Bortezomib	6 (85.7)
Carfilzomib	6 (85.7)
Ixazomib	2 (29.0)
Triple-class	7 (100.0)
Penta	6 (85.7)
Previous ASCT	7 (100.0)

Notes: Categorical variables are shown as n (%), and continuous variables are shown as median (minimum-maximum).

Abbreviations: ASCT, autologous stem cell transplantation; FISH, fluorescence in situ hybridization; MM, multiple myeloma; R-ISS, Revised International Staging System; y, years.

Table 2 Treatment Characteristics and Response to Treatment in 7 Subjects

Characteristic
Cycles
Median	5 (1–9)
1	2 (29.0)
2–5	3 (43.0)
6–10	2 (29.0)
Dose reduction (mg/wk)-total	4 (57.1)
40	2 (29.0)
80	2 (29.0)
Response
Very good partial response	2 (29.0)
Partial response	3 (43.0)
Stable disease	1 (14.3)
Progressive disease	1 (14.3)

Notes: Categorical variables are shown as n (%), and continuous variables are shown as median (minimum-maximum).

Figure 1 Best response to study treatment. Swim lane plot showing best response in patients treated with selinexor, bortezomib, and dexamethasone (XVd).

Abbreviations: PD, progressive disease; PR, partial response; SD, stable disease; VGPR, very good partial response.

Table 3 Adverse Events by Grade in 7 Subjects

Characteristic	Grade 1–2 n (%)	Grade 3–4 n (%)	Total n (%)
Hematologic AEs
Thrombocytopenia	1 (14.3)	6 (86.0)	7 (100.0)
Neutropenia	2 (29.0)	4 (57.1)	6 (86.0)
Non-Hematological AEs
Fatigue	3 (43.0)	–	3 (43.0)
Nausea	6 (86.0)	–	6 (86.0)
Weight loss	1 (14.3)	–	1 (14.3)
Dyspnea	–	1 (14.3)	1 (14.3)
Diarrhea	3 (43.0)	–	3 (43.0)
Upper respiratory infection	2 (29.0)	–	2 (29.0)
Pulmonary fibrosis	1 (14.3)	–	1 (14.3)
Pneumonia	1 (14.3)	–	1 (14.3)
Vomiting	1 (14.3)	–	1 (14.3)
Asthenia	1 (14.3)	–	1 (14.3)
Obstipation	1 (14.3)	–	1 (14.3)
Phase of acute delirium	1 (14.3)	–	1 (14.3)
General malaise	1 (14.3)	–	1 (14.3)
Anorexia	3 (43.0)	–	3 (43.0)

Note: Data are presented as n (%).

Abbreviation: AE, adverse event.