Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02780609
• Collaborator: Karyopharm Therapeutics Inc (Industry)
• Enrollment: 22
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 65.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Phase I: The primary purpose of this study phase is to determine the best dose also referred to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant.

Phase II: The primary purpose of this study phase is to assess the complete response (CR) conversion rate.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Selinexor; Drug: Melphalan; Drug: Dexamethasone; Procedure: Autologous Hematopoietic Cell Transplantation (HCT); Drug: Fosaprepitant	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
• Actual Study Start Date: Jul 20, 2017
• Actual Primary Completion Date: Feb 20, 2021
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Selinexor Plus HDM HCT 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.

Drug: 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.; Other Names: KPT-330 ; Drug: Melphalan; Melphalan 100 mg/m^2 IV over 30-45 minutes.; Other Names: Alkeran ; Drug: Dexamethasone; Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).; Other Names: Decadron ; Procedure: Autologous Hematopoietic Cell Transplantation (HCT); Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.; Drug: Fosaprepitant; Fosaprepitant at 150 mg IV on days -3 and -2.; Other Names: antiemetic agent Standare of Care

Outcome Measures

Primary Outcome Measures

1. Phase I: Recommended Phase II Dose (RPh2D) [Up to 3 months]

   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).

2. Complete Response (CR) [3 months post HCT]

   Complete 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.

Other Outcome Measures

1. Phase 1 and Phase 2 Percentage of Participants Treated at Dose Level 3/RP2D With Progression Free Survival (PFS) [at 24 months]

   Progression Free Survival defined as the time from start of treatment to the time of progression or death.

2. Overall Survival (OS) [at 24 months]

   Rate of participants' survival at time of evaluation.

3. Rate of Minimal Residual Disease (MRD) [3 months post HCT]

   Rate of participants who did not have Minimal Residual Disease (MRD) as assessed by flow cytometry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older with histologically confirmed multiple myeloma

• Achieving partial response (PR) or very good partial response (VGPR) with systemic chemotherapy

• Received less than 4 lines of anti-myeloma therapy.

• Karnofsky performance status of >= 70%

• Adequate pulmonary, cardiac, hepatic and renal function as outlined in the protocol

• Signed informed consent form in accordance with institutional policies prior to the initiation of high-dose therapy

Exclusion Criteria:

• Non-secretory multiple myeloma

• Have achieved complete response (CR) prior to autologous hematopoietic cell transplantation (HCT)

• Central nervous system (CNS) involvement

• Uncontrolled bacterial, viral or fungal infections

• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

• Prior malignancies within the last 5 years except resected basal cell carcinoma or treated cervical carcinoma in situ.

• Females who are pregnant or breastfeeding

• Have received other investigational drugs within 14 days prior to screening

• Prior autologous or allogeneic HCT

• Prior organ transplant or autoimmune disease requiring immunosuppressive therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute
• Karyopharm Therapeutics Inc

Investigators

• Principal Investigator: Taiga Nishihori, M.D., H. Lee Moffitt Cancer Center and Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 6, 2020

More Information

Additional Information:

• Moffitt Cancer Center Clinical Trials website

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT02780609
• Other Study ID Numbers: MCC-18630
• First Posted: May 23, 2016
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: autologous hematopoietic cell transplantation (HCT); high-dose melphalan; selinexor
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Melphalan; Fosaprepitant; Aprepitant; Antiemetics

Study Results

Participant Flow

Arm/Group Title	Phase 1 Level 1: Selinexor Plus HDM HCT	Phase 1 Level 2: Selinexor Plus HDM HCT	Phase 1 Level 3: Selinexor Plus HDM HCT	Phase 2: Selinexor Plus HDM HCT
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
STARTED	3	3	6	10
COMPLETED	3	3	6	10
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Phase 1 Level 1: Selinexor Plus HDM HCT	Phase 1 Level 2: Selinexor Plus HDM HCT	Phase 1 Level 3: Selinexor Plus HDM HCT	Phase 2: Selinexor Plus HDM HCT	Total
Arm/Group Description	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.	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.	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.	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 of all reporting groups
Overall Participants	3	3	6	10	22
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	2 66.7%	5 83.3%	9 90%	19 86.4%
>=65 years	0 0%	1 33.3%	1 16.7%	1 10%	3 13.6%
Sex: Female, Male (Count of Participants)
Female	1 33.3%	1 33.3%	3 50%	4 40%	9 40.9%
Male	2 66.7%	2 66.7%	3 50%	6 60%	13 59.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	3 100%	3 100%	6 100%	10 100%	22 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	1 33.3%	1 16.7%	3 30%	5 22.7%
White	3 100%	2 66.7%	5 83.3%	7 70%	17 77.3%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%	3 100%	6 100%	10 100%	22 100%

Outcome Measures

1. Primary Outcome

Title	Phase I: Recommended Phase II Dose (RPh2D)
Description	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).
Time Frame	Up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Selinexor Plus HDM HCT
Arm/Group Description	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.
Measure Participants	12
Number [mg]	80

2. Primary Outcome

Title	Complete Response (CR)
Description	Complete 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.
Time Frame	3 months post HCT

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1 Level 1: Selinexor Plus HDM HCT	Phase 1 Level 2: Selinexor Plus HDM HCT	Phase 1 Level 3: Selinexor Plus HDM HCT	Phase 2: Selinexor Plus HDM HCT
Arm/Group Description	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.	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).	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).	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.
Measure Participants	3	3	6	10
Number [percentage of participants with CR]	0 0%	33.3 1110%	16.6 276.7%	10 100%

3. Other Pre-specified Outcome

Title	Phase 1 and Phase 2 Percentage of Participants Treated at Dose Level 3/RP2D With Progression Free Survival (PFS)
Description	Progression Free Survival defined as the time from start of treatment to the time of progression or death.
Time Frame	at 24 months

Outcome Measure Data

Analysis Population Description

All evaluable participants treated at dose level 3/RP2D.

Arm/Group Title	Phase 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT
Arm/Group Description	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.
Measure Participants	15
Number (95% Confidence Interval) [percent of participants]	66.7 2223.3%

4. Other Pre-specified Outcome

Title	Overall Survival (OS)
Description	Rate of participants' survival at time of evaluation.
Time Frame	at 24 months

Outcome Measure Data

Analysis Population Description

All evaluable participants treated at dose level 3/RP2D.

Arm/Group Title	Phase 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT
Arm/Group Description	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.
Measure Participants	15
Number (95% Confidence Interval) [percent]	95.2

5. Other Pre-specified Outcome

Title	Rate of Minimal Residual Disease (MRD)
Description	Rate of participants who did not have Minimal Residual Disease (MRD) as assessed by flow cytometry.
Time Frame	3 months post HCT

Outcome Measure Data

Analysis Population Description

Evaluable participants

Arm/Group Title	Phase 1 Level 1: Selinexor Plus HDM HCT	Phase 1 Level 2: Selinexor Plus HDM HCT	Phase 1 Level 3: Selinexor Plus HDM HCT	Phase 2: Selinexor Plus HDM HCT
Arm/Group Description	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.	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).	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).	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.
Measure Participants	3	2	6	9
Number [percentage of participants]	33.3 1110%	100 3333.3%	16.7 278.3%	33.3 333%

Adverse Events

Time Frame	Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
Arm/Group Title	Phase 1 Level 1: Selinexor Plus HDM HCT		Phase 1 Level 2: Selinexor Plus HDM HCT		Phase 1 Level 3: Selinexor Plus HDM HCT		Phase 2: Selinexor Plus HDM HCT
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	Phase 1 Level 1: Selinexor Plus HDM HCT		Phase 1 Level 2: Selinexor Plus HDM HCT		Phase 1 Level 3: Selinexor Plus HDM HCT		Phase 2: Selinexor Plus HDM HCT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		0/3 (0%)		2/6 (33.3%)		0/10 (0%)
Serious Adverse Events
	Phase 1 Level 1: Selinexor Plus HDM HCT		Phase 1 Level 2: Selinexor Plus HDM HCT		Phase 1 Level 3: Selinexor Plus HDM HCT		Phase 2: Selinexor Plus HDM HCT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		2/3 (66.7%)		3/6 (50%)		5/10 (50%)
Blood and lymphatic system disorders
Febrile Neutropenia	2/3 (66.7%)	2	1/3 (33.3%)	1	0/6 (0%)	0	5/10 (50%)	5
Gastrointestinal disorders
Diarrhea	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Abdominal pain	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Small intestinal obstruction	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Nausea	1/3 (33.3%)	1	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Vomiting	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
General disorders
Fever	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	2	2/10 (20%)	2
Neck edema	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Infections and infestations
Sepsis	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Lung infection	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Urinary tract infection	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0	0/10 (0%)	0
Abdominal infection	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Metabolism and nutrition disorders
Hypernatremia	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Hyperglycemia	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0	0/10 (0%)	0
Nervous system disorders
Headache	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	1/10 (10%)	1
Renal and urinary disorders
Acute kidney injury	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	2	0/10 (0%)	0
Vascular disorders
Hypotension	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Thromboembolic event	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Phase 1 Level 1: Selinexor Plus HDM HCT		Phase 1 Level 2: Selinexor Plus HDM HCT		Phase 1 Level 3: Selinexor Plus HDM HCT		Phase 2: Selinexor Plus HDM HCT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		2/3 (66.7%)		6/6 (100%)		10/10 (100%)
Blood and lymphatic system disorders
Anemia	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	5/10 (50%)	8
Febrile neutropenia	1/3 (33.3%)	1	1/3 (33.3%)	1	2/6 (33.3%)	2	5/10 (50%)	5
Gastrointestinal disorders
Diarrhea	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	2	1/10 (10%)	1
Nausea	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
General disorders
Gait disturbance	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Pain	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	1/10 (10%)	1
Fever	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	1/10 (10%)	1
Infections and infestations
Urinary tract infection	0/3 (0%)	0	1/3 (33.3%)	1	1/6 (16.7%)	1	0/10 (0%)	0
Catheter related infection	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Infections and infestations - Other	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Lung infection	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Sepsis	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Investigations
Neutrophil count decreased	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	3	8/10 (80%)	17
Platelet count decreased	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	3	10/10 (100%)	27
White blood cell decreased	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	3	10/10 (100%)	28
Metabolism and nutrition disorders
Hyperglycemia	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0	0/10 (0%)	0
Nervous system disorders
Dizziness	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Peripheral sensory neuropathy	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	1/10 (10%)	1
Renal and urinary disorders
Acute kidney injury	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	3	0/10 (0%)	0
Vascular disorders
Hypotension	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Thromboembolic event	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.