Trial Outcomes & Findings for Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma (NCT NCT02780609)
NCT ID: NCT02780609
Last Updated: 2022-11-04
Results Overview
RPh2D/Maximum Tolerated Dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant. MTD: the highest dose level at which 1 or less of 6 participants experience a dose limiting toxicity (DLT).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 3 months
Results posted on
2022-11-04
Participant Flow
Participant milestones
| Measure |
Phase 1 Level 1: Selinexor Plus HDM HCT
40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 3: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 2: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
10
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1 Level 1: Selinexor Plus HDM HCT
n=3 Participants
40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
n=3 Participants
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 3: Selinexor Plus HDM HCT
n=6 Participants
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 2: Selinexor Plus HDM HCT
n=10 Participants
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
22 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsRPh2D/Maximum Tolerated Dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant. MTD: the highest dose level at which 1 or less of 6 participants experience a dose limiting toxicity (DLT).
Outcome measures
| Measure |
Selinexor Plus HDM HCT
n=12 Participants
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
Selinexor: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 1 Level 3: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 2: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Phase I: Recommended Phase II Dose (RPh2D)
|
80 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 months post HCTComplete response (CR) conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. Complete Response conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.
Outcome measures
| Measure |
Selinexor Plus HDM HCT
n=3 Participants
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
Selinexor: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
n=3 Participants
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 1 Level 3: Selinexor Plus HDM HCT
n=6 Participants
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 2: Selinexor Plus HDM HCT
n=10 Participants
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Complete Response (CR)
|
0 percentage of participants with CR
|
33.3 percentage of participants with CR
|
16.6 percentage of participants with CR
|
10 percentage of participants with CR
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 24 monthsPopulation: All evaluable participants treated at dose level 3/RP2D.
Progression Free Survival defined as the time from start of treatment to the time of progression or death.
Outcome measures
| Measure |
Selinexor Plus HDM HCT
n=15 Participants
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
Selinexor: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 1 Level 3: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 2: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2 Percentage of Participants Treated at Dose Level 3/RP2D With Progression Free Survival (PFS)
|
66.7 percent of participants
Interval 35.8 to 85.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 24 monthsPopulation: All evaluable participants treated at dose level 3/RP2D.
Rate of participants' survival at time of evaluation.
Outcome measures
| Measure |
Selinexor Plus HDM HCT
n=15 Participants
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
Selinexor: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 1 Level 3: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 2: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
95.2 percent
Interval 70.7 to 99.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post HCTPopulation: Evaluable participants
Rate of participants who did not have Minimal Residual Disease (MRD) as assessed by flow cytometry.
Outcome measures
| Measure |
Selinexor Plus HDM HCT
n=3 Participants
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
Selinexor: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
n=2 Participants
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 1 Level 3: Selinexor Plus HDM HCT
n=6 Participants
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
|
Phase 2: Selinexor Plus HDM HCT
n=9 Participants
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Rate of Minimal Residual Disease (MRD)
|
33.3 percentage of participants
|
100 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
Adverse Events
Phase 1 Level 1: Selinexor Plus HDM HCT
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1 Level 2: Selinexor Plus HDM HCT
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1 Level 3: Selinexor Plus HDM HCT
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 2: Selinexor Plus HDM HCT
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Level 1: Selinexor Plus HDM HCT
n=3 participants at risk
40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
n=3 participants at risk
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 3: Selinexor Plus HDM HCT
n=6 participants at risk
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 2: Selinexor Plus HDM HCT
n=10 participants at risk
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
66.7%
2/3 • Number of events 2 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
50.0%
5/10 • Number of events 5 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
10.0%
1/10 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
2/6 • Number of events 2 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
20.0%
2/10 • Number of events 2 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 2 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
General disorders
Neck edema
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
Other adverse events
| Measure |
Phase 1 Level 1: Selinexor Plus HDM HCT
n=3 participants at risk
40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 2: Selinexor Plus HDM HCT
n=3 participants at risk
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 1 Level 3: Selinexor Plus HDM HCT
n=6 participants at risk
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
Phase 2: Selinexor Plus HDM HCT
n=10 participants at risk
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion
Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
50.0%
5/10 • Number of events 8 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
2/6 • Number of events 2 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
10.0%
1/10 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
2/6 • Number of events 2 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
50.0%
5/10 • Number of events 5 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
80.0%
8/10 • Number of events 17 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
10.0%
1/10 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
10.0%
1/10 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
100.0%
10/10 • Number of events 27 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
2/6 • Number of events 3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
100.0%
10/10 • Number of events 28 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
10.0%
1/10 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
16.7%
1/6 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Number of events 1 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/3 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/6 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
0.00%
0/10 • Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place