Trial Outcomes & Findings for Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma (NCT NCT01029054)

Last Updated: 2017-01-30

Results Overview

The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined. sCR is defined as: * Negative immunofixation on the serum and urine and * Disappearance of any soft tissue plasmacytomas and * \< 5% plasma cells in bone marrow and * Normal SFLC ratio and * Absence of clonal cells in bone marrow VGPR is defined as: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis or * ≥ 90% reduction in serum M-component with urine M-component \< 100 mg per 24 hours PR is defined as: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

53 participants

Primary outcome timeframe

4 Months After Treatment Start

Results posted on

2017-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Escalation Cohort 1 Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 20 mg/m\^2. Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.	Dose Escalation Cohort 2 Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 27 mg/m\^2. Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.	Dose Escalation Cohort 3 Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 36 mg/m\^2. Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
Phase I STARTED	4	13	18
Phase I COMPLETED	4	13	18
Phase I NOT COMPLETED	0	0	0
Phase II STARTED	0	0	18
Phase II COMPLETED	0	0	18
Phase II NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carfilzomib, Lenalidomide w/Dexamethasone n=53 Participants Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
Age, Continuous	59 years n=5 Participants
Gender Female	14 Participants n=5 Participants
Gender Male	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Of the 53 patients enrolled, 35 were entered into the Phase I portion of the study.

Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide w/Dexamethasone n=35 Participants Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
The Maximum Tolerated Dose (MTD) of Carfilzomib	36 mg/m^2

PRIMARY outcome

Timeframe: 4 Months After Treatment Start

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide w/Dexamethasone n=53 Participants Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
The Percentage of Patients That Achieve a Response to Treatment % of patients that achieve at least a sCR	42 percentage of patients
The Percentage of Patients That Achieve a Response to Treatment % of patients that achieve at least a VGPR	81 percentage of patients
The Percentage of Patients That Achieve a Response to Treatment % of patients that achieve at least a PR	98 percentage of patients

SECONDARY outcome

Timeframe: 12 Months and 24 Months Post Treatment

The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment. Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide w/Dexamethasone n=53 Participants Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
The Percentage of Patients Alive Without Progression Percentage of Patients Without Progression at 12 m	97 percentage of patients
The Percentage of Patients Alive Without Progression Percentage of Patients Without Progression at 24 m	92 percentage of patients

Adverse Events

Carfilzomib, Lenalidomide w/Dexamethasone

Serious events: 23 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Carfilzomib, Lenalidomide w/Dexamethasone n=53 participants at risk Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
Renal and urinary disorders Acute Renal Failure	3.8% 2/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Nervous system disorders Acute Mental Status Change	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Infections and infestations Appendicitis	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Cardiac disorders Atrial Fibrillation	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Infections and infestations Clostridium Difficile	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Gastrointestinal disorders Colitis	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Musculoskeletal and connective tissue disorders Compression Fracture	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Nervous system disorders Confusion	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Gastrointestinal disorders Constipation	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 2/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Blood and lymphatic system disorders Febrile Neutropenia	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
General disorders Fever	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Gastrointestinal disorders Gastroenteritis	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Nervous system disorders Grand Mal Seizure	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Metabolism and nutrition disorders Hyperglycemia	3.8% 2/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Infections and infestations Pneumonia	7.5% 4/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Infections and infestations Influenza	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Blood and lymphatic system disorders Anemia	3.8% 2/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Vascular disorders Intracranial Hemorrhage	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Blood and lymphatic system disorders Methemoglobinemia	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Respiratory, thoracic and mediastinal disorders Pulmonary Toxicity	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Cardiac disorders Rapid Ventricular Response	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Nervous system disorders Seizure	1.9% 1/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Infections and infestations Urinary Tract Infection	5.7% 3/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.

Other adverse events

Other adverse events
Measure	Carfilzomib, Lenalidomide w/Dexamethasone n=53 participants at risk Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
Metabolism and nutrition disorders Hyperglycemia	71.7% 38/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
General disorders Edema	47.2% 25/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Metabolism and nutrition disorders Hypophosphatemia	45.3% 24/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
General disorders Fatigue	37.7% 20/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Musculoskeletal and connective tissue disorders Muscle Cramping	32.1% 17/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Skin and subcutaneous tissue disorders Rash	28.3% 15/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Investigations Elevated Liver Function Test	28.3% 15/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Gastrointestinal disorders Diarrhea	26.4% 14/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Infections and infestations Infection	22.6% 12/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Vascular disorders Phlebitis	22.6% 12/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Nervous system disorders Peripheral Neuropathy	22.6% 12/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.1% 8/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Vascular disorders Deep Vein Thrombosis	11.3% 6/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	5.7% 3/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Gastrointestinal disorders Nausea	13.2% 7/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Renal and urinary disorders Renal	9.4% 5/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Gastrointestinal disorders Constipation	9.4% 5/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Psychiatric disorders Mood Alterations	9.4% 5/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Blood and lymphatic system disorders Thrombocytopenia	67.9% 36/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Blood and lymphatic system disorders Anemia	60.4% 32/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.
Blood and lymphatic system disorders Neutropenia	30.2% 16/53 • All Adverse Events (AEs) that occurred after the subject signed consent were documented. A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.

Additional Information

Dr. Mark Kaminski, M.D.

University of Michigan Hospital

Phone: 734-936-5310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place