A Phase 1 interventional study of KPT-330 in Hematological Malignancies, sponsored by Karyopharm Therapeutics Inc. Completed at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Karyopharm Therapeutics Inc · Phase 1, Interventional, and Treatment
The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.
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Exclusion Criteria
Drug: KPT-330
Also known as: Selinexor
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment.
Time frame: From first dose of study drug administration to end of treatment (up to 27 months)
Recommended Phase 2 Dose (RP2D) of Selinexor
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which \> 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was \>25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.
Time frame: From first dose of study drug administration to end of treatment (up to 27 months)
Maximum Observed Plasma Concentration (Cmax) of Selinexor
Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Time to Maximum Observed Concentration (Tmax) of Selinexor
Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor
Cavg0-24h was defined as average concentration from time 0 to 24 hours.
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor
AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor
AUC0-inf was defined as the area under the concentration-time curve from time zero to infinity (extrapolated).
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor
Apparent volume of distribution was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed, reported normalized by participant body weight (kilogram \[kg\]).
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor
Cl/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed, reported normalized by participant body weight (kg).
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Terminal Half-Life (t½) of Selinexor
t½ was, calculated as ln(2)/kel, where kel is elimination rate constant, calculated using linear regression on the terminal portion of the log-linear concentration versus time curve.
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Number of Participants With Overall Response of Selinexor
Objective response for each malignancy was defined using the disease response criteria by malignancy; For NHL (including DLBCL, PTCL, and CTCL), objective response included complete response (CR) and partial response (PR). For MM, objective response included stringent complete response (sCR), CR, very good partial response (VGPR), and PR. For WM, objective response included CR, VGPR, and PR. For CLL, ALL, and AML, objective response included complete remission and Partial remission. For CML, objective response includes complete cytogenic response, and complete hematologic response (CHR).
Time frame: From first dose of study drug administration to end of treatment (up to 27 months)
Duration of Response
Duration of response was defined as the time from the first occurrence of objective response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment. Objective response was defined as any response of partial response/remission or better for all malignancies; for AML, a response of morphologic leukemia-free state is also included for ORR. Duration of response was calculated by Kaplan-Meier method.
Time frame: From first dose of study drug administration to end of treatment (up to 27 months)
Progression-free Survival
Progression-free survival (PFS) was calculated from the date of first dose of study drug to first documented evidence of disease recurrence or progression or death due to any cause. Participants who were last known to be alive and without evidence of progression were censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.
Time frame: Cycle 1 Day 1 to End of Treatment (up to 27 months)
Duration of at Least Stable Disease
Duration of at least stable disease was defined as the time from the date of first dose of study drug to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment.
Time frame: Cycle 1 Day 1 to End of Treatment (up to 27 months)
Overall Survival
Overall Survival was calculated from the date of first dose of study drug to date of death due to any cause. Participants who were last known to be alive were censored at time of last contact. Overall survival was calculated by Kaplan-Meier method.
Time frame: Cycle 1 Day 1 to End of Treatment (up to 27 months)
The study was conducted at 12 sites in United States, Canada and Europe between 23 July 2012 (first participant treated) and 13 October 2015 (last participant completed).
| Milestone | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| Started | 58 | 27 | 81 | 95 | 24 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 58 | 27 | 81 | 95 | 24 |
| Withdrew: Need of treatment not allowed per protocol | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Death | 4 | 2 | 8 | 10 | 3 |
| Withdrew: Investigator discretion | 2 | 4 | 4 | 8 | 0 |
| Withdrew: Other treatments became available | 1 | 1 | 0 | 0 | 2 |
| Withdrew: Intercurrent illness | 1 | 0 | 0 | 3 | 0 |
| Withdrew: Non-compliance with study procedures | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Consent withdrawn by participant | 9 | 4 | 24 | 14 | 4 |
| Withdrew: Disease progression | 38 | 13 | 37 | 57 | 9 |
| Withdrew: Incidence or severity of adverse events | 3 | 3 | 7 | 2 | 6 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment.
| Participants | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| At Least One TEAE | 58 | 27 | 81 | 95 | 24 |
| At Least One Serious TEAE | 33 | 7 | 52 | 73 | 13 |
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which \> 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was \>25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.
| milligram per square meter (mg/m^2) | Advanced Hematological Malignancies. |
|---|---|
| Recommended Phase 2 Dose (RP2D) of Selinexor | 35 |
Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.
| nanogram per milliliter (ng/mL) | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Selinexor | 49.0 ± NA | 50.0 ± 61.1 | 149 ± 37.6 | 205 ± 46.8 | 262 ± 37.5 | 387 ± 37.1 | 407 ± 44.4 | 416 ± 36.6 | 670 ± 18.5 | 583 ± 41.4 | 668 ± 33.2 | 800 ± 32.4 | 1068 ± 49.3 |
Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
| hour | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time to Maximum Observed Concentration (Tmax) of Selinexor | NA (2.1 to 2.2) | 4.0 (2.1 to 7.7) | 3.0 (1.1 to 4.2) | 2.08 (0.92 to 8.5) | 2.0 (1.0 to 7.8) | 2.0 (0.72 to 4.4) | 2.0 (0.92 to 4.1) | 4.0 (2.0 to 7.5) | 2.0 (0.50 to 4.2) | 2.9 (1.0 to 8.0) | 1.9 (1.8 to 2.0) | 2.0 (1.0 to 4.0) | 2.0 (0.5 to 4.0) |
Cavg0-24h was defined as average concentration from time 0 to 24 hours.
| ng/mL | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor | 17.0 ± NA | 20.3 ± 94.8 | 61.8 ± 39.9 | 79.0 ± 61.8 | 108 ± 46.8 | 160 ± 38.0 | 168 ± 54.0 | 163 ± 29.2 | 297 ± 26.3 | 208 ± 19.1 | 337 ± 4.2 | 353 ± 26.2 | NA ± NA |
AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
| nanogram* hours per milliliter | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor | 331 ± NA | 564 ± 41.9 | 1459 ± 20.5 | 1829 ± 23.3 | 2774 ± 36.7 | 3461 ± 26.9 | 3901 ± 29.2 | 4481 ± 23.8 | 5228 ± 21.6 | 5601 ± 36.2 | 5282 ± 57.9 | 5466 ± 45.7 | 5544 ± 33.2 |
AUC0-inf was defined as the area under the concentration-time curve from time zero to infinity (extrapolated).
| ng*h/mL | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor | 348 ± NA | 733 ± NA | 1529 ± 18.7 | 1867 ± 23.6 | 2645 ± 1111 | 3513 ± 26.0 | 3948 ± 28.6 | 4552 ± 23.7 | 5284 ± 21.0 | 6089 ± 32.3 | 6964 ± 12.2 | 7803 ± 8.5 | NA ± NA |
Apparent volume of distribution was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed, reported normalized by participant body weight (kilogram \[kg\]).
| Liter per kilogram (L/kg) | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor | 1.6 ± NA | 1.5 ± NA | 1.9 ± 21.2 | 1.9 ± 29.9 | 1.9 ± 34.1 | 1.7 ± 24.1 | 2.0 ± 30.3 | 1.7 ± 29.1 | 1.8 ± 12.9 | 1.9 ± 27.9 | 1.6 ± 23.0 | 1.7 ± 13.4 | NA ± NA |
Cl/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed, reported normalized by participant body weight (kg).
| Liter per hour per kilogram (L/h/kg) | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor | 0.19 ± NA | 0.21 ± NA | 0.21 ± 26.6 | 0.22 ± 22.8 | 0.20 ± 54.9 | 0.21 ± 25.3 | 0.22 ± 25.9 | 0.23 ± 26.2 | 0.22 ± 12.9 | 0.20 ± 24.6 | 0.19 ± 27.5 | 0.22 ± 7.8 | NA ± NA |
t½ was, calculated as ln(2)/kel, where kel is elimination rate constant, calculated using linear regression on the terminal portion of the log-linear concentration versus time curve.
| hour | Selinexor (3 mg/m^2) | Selinexor (6 mg/m^2) | Selinexor (12 mg/m^2) | Selinexor (16.8 mg/m^2) | Selinexor (23 mg/m^2) | Selinexor (30 mg/m^2) | Selinexor (35 mg/m^2) | Selinexor (40 mg/m^2) | Selinexor (46 mg/m^2) | Selinexor (55 mg/m^2) | Selinexor (60 mg/m^2) | Selinexor (70 mg/m^2) | Selinexor (80 mg/m^2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Terminal Half-Life (t½) of Selinexor | NA (5.5 to 6.1) | NA (4.4 to 5.1) | 6.2 (4.2 to 7.8) | 6.1 (3.1 to 8.7) | 6.9 (3.5 to 12.0) | 5.8 (3.9 to 8.4) | 6.2 (4.6 to 10.4) | 4.8 (2.7 to 9.8) | 5.7 (4.1 to 6.8) | 6.6 (5.4 to 10.1) | 5.9 (4.3 to 5.9) | 5.2 (5.0 to 6.0) | NA (5.5 to 5.5) |
Objective response for each malignancy was defined using the disease response criteria by malignancy; For NHL (including DLBCL, PTCL, and CTCL), objective response included complete response (CR) and partial response (PR). For MM, objective response included stringent complete response (sCR), CR, very good partial response (VGPR), and PR. For WM, objective response included CR, VGPR, and PR. For CLL, ALL, and AML, objective response included complete remission and Partial remission. For CML, objective response includes complete cytogenic response, and complete hematologic response (CHR).
| participants | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| Complete response | 5 | 1 | 0 | 0 | 0 |
| Partial response | 7 | 8 | 6 | 0 | 0 |
| Morphologic complete remission | 0 | 0 | 0 | 4 | 0 |
| Partial remission | 0 | 0 | 0 | 3 | 1 |
| Complete cytogenetic response | 0 | 0 | 0 | 0 | 0 |
| Complete hematological response | 0 | 0 | 0 | 0 | 0 |
Duration of response was defined as the time from the first occurrence of objective response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment. Objective response was defined as any response of partial response/remission or better for all malignancies; for AML, a response of morphologic leukemia-free state is also included for ORR. Duration of response was calculated by Kaplan-Meier method.
| Days | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| Duration of Response | 335.5 (48 to NA) | 251 (36 to NA) | 180 (57 to NA) | 76 (29 to NA) | NA (NA to NA) |
Progression-free survival (PFS) was calculated from the date of first dose of study drug to first documented evidence of disease recurrence or progression or death due to any cause. Participants who were last known to be alive and without evidence of progression were censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.
| Days | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| Progression-free Survival | 47 (31 to 56) | 110 (28 to 274) | 57 (36 to 88) | 44 (36 to 52) | 57 (24 to 222) |
Duration of at least stable disease was defined as the time from the date of first dose of study drug to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment.
| Days | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| Duration of at Least Stable Disease | 52 (32 to 79) | 114 (43 to 415) | 57 (43 to 100) | 80 (52 to 101) | 64 (21 to 283) |
Overall Survival was calculated from the date of first dose of study drug to date of death due to any cause. Participants who were last known to be alive were censored at time of last contact. Overall survival was calculated by Kaplan-Meier method.
| Days | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| Overall Survival | 138 (85 to NA) | 423 (423 to NA) | 366 (126 to NA) | 76 (48 to 114) | 82 (50 to NA) |
Collected over From first dose of study drug administration to end of treatment (up to 27 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma (DLBCL) | — | 33/58 (56.9%) | 58/58 (100%) |
| Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | — | 7/27 (25.9%) | 27/27 (100%) |
| Multiple Myeloma (MM) | — | 52/81 (64.2%) | 80/81 (98.8%) |
| Acute Myeloid Leukemia (AML) | — | 73/95 (76.8%) | 94/95 (98.9%) |
| Other Hematological Malignancies (ALL, CML and CLL) | — | 13/24 (54.2%) | 24/24 (100%) |
| Event | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| SepsisInfections and infestations | 3/58 | 1/27 | 2/81 | 14/95 | 0/24 |
| Febrile neutropeniaBlood and lymphatic system disorders | 4/58 | 1/27 | 6/81 | 12/95 | 0/24 |
| PneumoniaInfections and infestations | 2/58 | 0/27 | 8/81 | 10/95 | 2/24 |
| Lung infectionInfections and infestations | 2/58 | 1/27 | 1/81 | 4/95 | 2/24 |
| FatigueGeneral disorders | 0/58 | 0/27 | 1/81 | 6/95 | 0/24 |
| PyrexiaGeneral disorders | 3/58 | 0/27 | 5/81 | 1/95 | 0/24 |
| DehydrationMetabolism and nutrition disorders | 2/58 | 0/27 | 3/81 | 5/95 | 0/24 |
| Confusional stateGeneral disorders | 3/58 | 0/27 | 1/81 | 0/95 | 0/24 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/58 | 0/27 | 4/81 | 2/95 | 0/24 |
| Acute kidney injuryRenal and urinary disorders | 1/58 | 0/27 | 4/81 | 1/95 | 0/24 |
| Event | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 38/58 | 18/27 | 64/81 | 55/95 | 18/24 |
| FatigueGeneral disorders | 39/58 | 13/27 | 62/81 | 67/95 | 16/24 |
| ThrombocytopeniaBlood and lymphatic system disorders | 39/58 | 15/27 | 52/81 | 47/95 | 17/24 |
| AnaemiaBlood and lymphatic system disorders | 34/58 | 14/27 | 42/81 | 46/95 | 16/24 |
| Decreased appetiteMetabolism and nutrition disorders | 34/58 | 16/27 | 54/81 | 62/95 | 13/24 |
| VomitingGastrointestinal disorders | 25/58 | 11/27 | 40/81 | 39/95 | 9/24 |
| DiarrhoeaGastrointestinal disorders | 24/58 | 9/27 | 32/81 | 46/95 | 10/24 |
| HyponatraemiaMetabolism and nutrition disorders | 25/58 | 7/27 | 36/81 | 34/95 | 11/24 |
| NeutropeniaBlood and lymphatic system disorders | 23/58 | 12/27 | 31/81 | 23/95 | 10/24 |
| Weight decreasedInvestigations | 14/58 | 10/27 | 32/81 | 31/95 | 3/24 |
Safety population consisted of all participants who received at least 1 dose of selinexor.
| Age, Continuous(years) | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) | Total |
|---|---|---|---|---|---|---|
| Mean | 57.8 ± 14.00 | 58.0 ± 15.90 | 62.1 ± 8.76 | 65.6 ± 15.33 | 60.9 ± 15.23 | 61.9 ± 13.79 |
| Sex: Female, Male(Participants) | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) | Total |
|---|---|---|---|---|---|---|
| Female | 28 | 9 | 38 | 40 | 8 | 123 |
| Male | 30 | 18 | 43 | 55 | 16 | 162 |
| Ethnicity (NIH/OMB)(Participants) | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 4 | 2 | 0 | 9 |
| Not Hispanic or Latino | 52 | 23 | 72 | 88 | 23 | 258 |
| Unknown or Not Reported | 4 | 3 | 5 | 5 | 1 | 18 |
| Race/Ethnicity, Customized(Participants) | Diffuse Large B-cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | Multiple Myeloma (MM) | Acute Myeloid Leukemia (AML) | Other Hematological Malignancies (ALL, CML and CLL) | Total |
|---|---|---|---|---|---|---|
| White | 52 | 20 | 65 | 88 | 23 | 248 |
| Black | 2 | 3 | 11 | 5 | 1 | 22 |
| Asian | 0 | 1 | 4 | 1 | 1 | 7 |
| Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| American Indian or Alaskan Native | 0 | 1 | 0 | 0 | 0 | 1 |
| Other | 0 | 2 | 1 | 0 | 0 | 3 |
| Unknown/Not Reported | 4 | 0 | 0 | 1 | 0 | 5 |
Plan to share: Yes
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Karyopharm Therapeutics Inc