Trial Outcomes & Findings for PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation (NCT NCT00925782)

Last Updated: 2019-12-17

Results Overview

AUC (0-t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Day -3 and Day -2

Results posted on

2019-12-17

Participant Flow

The study was conducted at a single study center (University of Kansas Medical Center -two facilities) in the United States under the direction of the investigator, Omar S. Aljitawi, M.D.

No patients that were enrolled in the study were excluded from the trial prior to assignment to groups.

Participant milestones

Participant milestones
Measure	Melphalan - Alkeran Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder \[equivalent to 50 mg of melphalan free base\] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter. Alkeran for Injection (single-use glass vial containing melphalan HCl powder \[equivalent to 50 mg melphalan\] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.	Alkeran - Melphalan Randomized group of Alkeran-Melphalan Alkeran for Injection (single-use glass vial containing melphalan HCl powder \[equivalent to 50 mg melphalan\] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter. Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder \[equivalent to 50 mg of melphalan free base\] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.
Pretreatment (Day -30 to Day -3) STARTED	12	12
Pretreatment (Day -30 to Day -3) COMPLETED	12	12
Pretreatment (Day -30 to Day -3) NOT COMPLETED	0	0
Study Period (Day -3 to Day 0) STARTED	12	12
Study Period (Day -3 to Day 0) COMPLETED	12	12
Study Period (Day -3 to Day 0) NOT COMPLETED	0	0
Follow-up(Day +1 to Date of Engraftment) STARTED	12	12
Follow-up(Day +1 to Date of Engraftment) COMPLETED	12	12
Follow-up(Day +1 to Date of Engraftment) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=24 Participants Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Day -3 and Day -2

Population: The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection. The results are presented by each drug group that combines data from both sequence.

Outcome measures

Outcome measures
Measure	Melphalan n=24 Participants Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence	Alkeran n=24 Participants Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
Area Under the Curve (0-t)	376577 min*ng/mL Standard Deviation 93401 • Interval 105.0 to 118.0	341183 min*ng/mL Standard Deviation 91349

PRIMARY outcome

Timeframe: Day -3 and Day -2

Population: The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate subsequent pharmacokinetic blood draws for the calculation of area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) for both Melphalan HCl for Injection and Alkeran for Injection.

Cmax was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The Cmax results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2.

Outcome measures

Outcome measures
Measure	Melphalan n=24 Participants Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence	Alkeran n=24 Participants Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
Concentration-Max (Cmax)	4374 ng/mL Standard Deviation 1050 • Interval 105.0 to 117.0	3931 ng/mL Standard Deviation 1034

SECONDARY outcome

Timeframe: 30 days

Population: The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.

ANC \<0.5 × 109/L, absolute lymphocyte count (ALC) \<0.1 × 109/L, platelet count \<20,000/mm3, or bleeding requiring transfusion. The first of 2 consecutive days for which cell counts drop below these cutoff levels was recorded as the date of myeloablation. Since the two treatments were administered consecutively with 1 day rest, the time to myeloablation and myeloablation rate was measured after both treatments were administered. Comparison of sequence effect was not planned in the study and due to small sample size, it was not performed.

Outcome measures

Outcome measures
Measure	Melphalan n=24 Participants Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence	Alkeran Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
Determination of Myeloablation Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT	3 days Standard Deviation 1	—

SECONDARY outcome

Timeframe: 30 days

Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed. Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered.

Outcome measures

Outcome measures
Measure	Melphalan n=24 Participants Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence	Alkeran Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT	11 days Standard Deviation 1	—

Adverse Events

All Study Participants

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Study Participants n=24 participants at risk Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
General disorders Mucosal inflammation (grade 3)	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Fatigue (grade 3)	4.2% 1/24 • Number of events 1 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Blood and lymphatic system disorders Febrile neutropenia (grade 3)	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Cardiac disorders Bundle branch block (grade 3)	4.2% 1/24 • Number of events 1 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Infections and infestations Sepsis (grade 4)	4.2% 1/24 • Number of events 1 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence

Other adverse events

Other adverse events
Measure	All Study Participants n=24 participants at risk Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
Respiratory, thoracic and mediastinal disorders Hiccups	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Nausea	100.0% 24/24 • Number of events 24 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Diarrhoea	95.8% 23/24 • Number of events 23 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Vomiting	87.5% 21/24 • Number of events 21 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Dry mouth	45.8% 11/24 • Number of events 11 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Stomatitis	37.5% 9/24 • Number of events 9 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Constipation	33.3% 8/24 • Number of events 8 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Abdominal pain	29.2% 7/24 • Number of events 7 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Dysphagia	25.0% 6/24 • Number of events 6 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Dyspepsia	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Gastroesophageal reflux	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Abdominal tenderness	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Anorectal discomfort	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Epigastric discomfort	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Gastrointestinal sounds abnormal	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Odynophagia	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Oesophageal pain	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Oesophagitis	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Gastrointestinal disorders Oral disorder	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Hypokalaemia	87.5% 21/24 • Number of events 21 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Decreased appetite	62.5% 15/24 • Number of events 15 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Fluid retention	41.7% 10/24 • Number of events 10 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Dehydration	20.8% 5/24 • Number of events 5 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Hyponatraemia	16.7% 4/24 • Number of events 4 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Hypomagnesaemia	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Hypophagia	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Metabolism and nutrition disorders Hypophosphataemia	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Fatigue	83.3% 20/24 • Number of events 20 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Mucosal inflammation	45.8% 11/24 • Number of events 11 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Oedema peripheral	45.8% 11/24 • Number of events 11 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Pyrexia	45.8% 11/24 • Number of events 11 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Asthenia	25.0% 6/24 • Number of events 6 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Chest pain	20.8% 5/24 • Number of events 5 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Malaise	20.8% 5/24 • Number of events 5 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
General disorders Chills	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Investigations Platelet count decreased	50.0% 12/24 • Number of events 12 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Investigations Weight increased	37.5% 9/24 • Number of events 9 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Investigations Weight decreased	16.7% 4/24 • Number of events 4 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Investigations Blood pressure increased	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Investigations White blood cell count decreased	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	37.5% 9/24 • Number of events 9 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Cough	25.0% 6/24 • Number of events 6 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.8% 5/24 • Number of events 5 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.8% 5/24 • Number of events 5 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 4/24 • Number of events 4 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	16.7% 4/24 • Number of events 4 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Increased viscosity of bronchial secretion	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Nervous system disorders Dizziness	62.5% 15/24 • Number of events 15 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Nervous system disorders Headache	37.5% 9/24 • Number of events 9 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Nervous system disorders Hypogeusia	20.8% 5/24 • Number of events 5 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Nervous system disorders Dysgeusia	16.7% 4/24 • Number of events 4 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Nervous system disorders Somnolence	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Muscular weakness	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Musculoskeletal pain	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Back pain	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Bone pain	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Musculoskeletal and connective tissue disorders Myalgia	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Blood and lymphatic system disorders Anaemia	29.2% 7/24 • Number of events 7 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Blood and lymphatic system disorders Thrombocytopenia	29.2% 7/24 • Number of events 7 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Blood and lymphatic system disorders Febrile neutropenia	25.0% 6/24 • Number of events 6 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Skin and subcutaneous tissue disorders Rash	16.7% 4/24 • Number of events 4 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Skin and subcutaneous tissue disorders Alopecia	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Skin and subcutaneous tissue disorders Petechiae	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Skin and subcutaneous tissue disorders Dry skin	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Skin and subcutaneous tissue disorders Erythema	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Skin and subcutaneous tissue disorders Hyperhidrosis	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Skin and subcutaneous tissue disorders Pruritus	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Cardiac disorders Tachycardia	20.8% 5/24 • Number of events 5 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Cardiac disorders Sinus tachycardia	16.7% 4/24 • Number of events 4 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Vascular disorders Hypotension	25.0% 6/24 • Number of events 6 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Vascular disorders Orthostatic hypotension	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Renal and urinary disorders Pollakiuria	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Eye disorders Vision blurred	12.5% 3/24 • Number of events 3 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence
Injury, poisoning and procedural complications Fall	8.3% 2/24 • Number of events 2 • Day -30 to 7 days post day of engraftment. The time between randomized sequence of treatment (24 hours) is not sufficiently long to evaluate adverse events by intervention and Adverse Events were not collected per sequence

Additional Information

Omar Aljitawi, M.D., Assistant Professor of Medicine

University of Kansas Medical Center

Phone: 913-588-6029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution/PI shall submit to the Sponsor for comment, any manuscript or public release of information at least 90 days prior to its submission or release. If the Sponsor requires additional time in order to protect the results of the Study by patenting or otherwise, Institution agrees to delay submitting the Publication to any third party for up to an additional 90 days after the request by Sponsor. Such request, however, must be received by Institution during the 90-day review period.
Publication restrictions are in place

Restriction type: OTHER