Trial Outcomes & Findings for Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma (NCT NCT03746080)

Last Updated: 2025-11-14

Results Overview

Proportion of Progression free survival will be measured at 6 months post initiation of chemoradiation. Simon 2-stage design will be use to assess progression-free survival. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

6 months

Results posted on

2025-11-14

Participant Flow

21 participants signed informed consent; 17 participants were allocated to treatment; 2 patients still in follow up

Participant milestones

Participant milestones
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	17
Overall Study On treatment	17
Overall Study Completed treatment	17
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Study In follow up	2
Overall Study Death	15

Baseline Characteristics

Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy n=17 Participants After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Age, Customized 18 to 30 years	1 Participants n=10 Participants
Age, Customized 31 to 39 years	1 Participants n=10 Participants
Age, Customized 40 to 49 years	3 Participants n=10 Participants
Age, Customized 50 to 59 years	6 Participants n=10 Participants
Age, Customized 60 to 69 years	4 Participants n=10 Participants
Age, Customized 70 to 79 years	2 Participants n=10 Participants
Sex: Female, Male Female	9 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	3 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants
Race (NIH/OMB) White	14 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Region of Enrollment United States	17 Participants n=10 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy n=17 Participants After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Proportion of Progression Free Survival Participants (PFS) at Six Months	0.786 Proportion of participants Interval 0.598 to 1.0

SECONDARY outcome

Timeframe: up to 31 months

Median survival will be assessed at 31 months of subjects who have completed the 28 day Plerixafor infusion. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy n=17 Participants After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Median Survival	398 days Standard Error 0.134

SECONDARY outcome

Timeframe: 30 days

Incidence of adverse events will be graded and recorded per Common Terminology Criteria for Adverse Events version 5.0. Will assess reported toxicities up until 30 days of treatment. The number of participants experiencing adverse events, including qualifying dose limiting toxicities (DLTs) will be tabulated by attribution (Unrelated, Unlikely to be related, Definitely related) and severity.

Outcome measures

Outcome measures
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy n=17 Participants After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Toxicity Associated With Plerixafor/WBRT Grade 3 or higher AE	3 Participants
Toxicity Associated With Plerixafor/WBRT Related to WBRT treatment	1 Participants
Toxicity Associated With Plerixafor/WBRT Related to Plerixafor treatment	0 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Participants with available scan data were included in the analysis

Patterns of Failure in patients receiving Whole Brain Radiotherapy + Plerixafor + Chemoradiotherapy was assessed by determining the out-of-field occurrence or occurrence outside of the brain over time. Local treatment failure was defined as within the 95% isodose region. Out-of-field occurrence is defined by any treatment failure observed outside treatment area.

Outcome measures

Outcome measures
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy n=14 Participants After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Patterns of Treatment Failure In Field Occurrence	12 Participants
Patterns of Treatment Failure Out-of-field Occurrence	2 Participants

Adverse Events

Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy

Serious events: 3 serious events

Other events: 16 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy n=17 participants at risk After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous system disorders Cerebral Edema	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pseudo Progession	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease Progression	5.9% 1/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.

Other adverse events

Other adverse events
Measure	Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy n=17 participants at risk After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Gastrointestinal Disorders Diarrhea	29.4% 5/17 • Number of events 5 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Gastrointestinal Disorders Dyspepsia	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Gastrointestinal Disorders Hypersalivation	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Gastrointestinal Disorders Nausea	70.6% 12/17 • Number of events 14 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Gastrointestinal Disorders Toothache	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Gastrointestinal Disorders Vomiting	35.3% 6/17 • Number of events 12 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
General Disorders Chills	17.6% 3/17 • Number of events 3 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
General Disorders Edema face	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
General Disorders Fatigue	64.7% 11/17 • Number of events 12 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
General Disorders Lump on the back of neck	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
General Disorders Gait disturbance	5.9% 1/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
General Disorders Non-cardiac chest pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
General Disorders Pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Infections and Infestations Conjunctivitis	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Infections and Infestations Shingles	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Infections and Infestations Thrush	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Injury, Poisoning and procedural complications Dermatitis radiation	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Investigations Blood bilirubin increased	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Investigations Creatinine increased	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Investigations Lymphocyte count decreased	35.3% 6/17 • Number of events 7 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Investigations Platelet count decreased	23.5% 4/17 • Number of events 6 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Metabolism and Nutrition Disorders Anorexia	17.6% 3/17 • Number of events 3 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Eye Disorders Eye Irritation	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Gastrointestinal Disorders Abdominal Pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Gastrointestinal Disorders Constipation	23.5% 4/17 • Number of events 4 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Blood and Lymphatic System Disorders Anemia	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Cardiac Disorders Palpitations	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Cardiac Disorders Supraventricular Tachycardia	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Ear and Labyrinth Disorders Tinnitus	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Ear and Labyrinth Disorders Hearing Impaired	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Eye Disorders Floaters	5.9% 1/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Eye Disorders Excessive Eye discharge/Rheum	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Metabolism and Nutrition Disorders Hypokalemia	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Metabolism and Nutrition Disorders Hyponatremia	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Musculoskeletal and Connective Tissue Disorders Neck Pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Musculoskeletal and Connective Tissue Disorders Muscle cramp	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Musculoskeletal and Connective Tissue Disorders Muscle weakness lower limb	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Musculoskeletal and Connective Tissue Disorders Pain in extremity	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Musculoskeletal and Connective Tissue Disorders Back pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Musculoskeletal and Connective Tissue Disorders Pain in extremity R foot	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Anosmia	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Ataxia	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Cognitive disturbance	17.6% 3/17 • Number of events 3 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Dizziness	23.5% 4/17 • Number of events 4 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Dysgeusia	11.8% 2/17 • Number of events 3 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Headache	29.4% 5/17 • Number of events 7 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Lethargy	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Memory Impairment	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Imbalance	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Muscle weakness left-sided	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Muscle weakness, lower limb	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Paresthesia	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Presyncope	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Somnolence	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Tremor	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Visual field disturbance	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Nervous System Disorders Right hand focal motor movement	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Confusion	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Agitation	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Delirium	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Depression	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Insomnia	23.5% 4/17 • Number of events 4 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Irritability	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Labile mood	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Suicidal ideation	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Psychiatric Disorders Anxiety	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Alopecia	58.8% 10/17 • Number of events 12 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Dry skin	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Erythema multiforme	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Pain of skin	17.6% 3/17 • Number of events 4 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Pruritus	17.6% 3/17 • Number of events 3 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Skin induration	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Skin and subcutaneous tissue disorders Urticaria	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Respiratory, Thoracic and Mediastinal Disorders Cough	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Respiratory, Thoracic and Mediastinal Disorders Dyspnea	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Respiratory, Thoracic and Mediastinal Disorders Allergic Rhinitis	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Respiratory, Thoracic and Mediastinal Disorders Epistaxis	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Respiratory, Thoracic and Mediastinal Disorders Sore throat	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Vascular Disorders Flushing	5.9% 1/17 • Number of events 1 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.
Vascular Disorders Hot flashes	11.8% 2/17 • Number of events 2 • All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.

Additional Information

Lawrence Recht, MD

Stanford University

Phone: (650) 725-8630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place