Trial Outcomes & Findings for Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation (NCT NCT01653418)
NCT ID: NCT01653418
Last Updated: 2014-10-15
Results Overview
Defined by the International Myeloma Working Group (IMWG) criteria
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Day +100
Results posted on
2014-10-15
Participant Flow
The study opened to participant enrollment on 09/20/2012 and closed to participant enrollment on 06/18/2013.
Participant milestones
| Measure |
V-BEAM + Stem Cell Infusion
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
V-BEAM + Stem Cell Infusion
n=10 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Age, Continuous
|
64.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
|
Durie-Salmon Stage of Myeloma on Diagnosis
Stage I
|
0 participants
n=99 Participants
|
|
Durie-Salmon Stage of Myeloma on Diagnosis
Stage IIA
|
3 participants
n=99 Participants
|
|
Durie-Salmon Stage of Myeloma on Diagnosis
Stage IIIA
|
7 participants
n=99 Participants
|
|
International Staging System (ISS) Stage of Myeloma on Diagnosis
Stage I
|
2 participants
n=99 Participants
|
|
International Staging System (ISS) Stage of Myeloma on Diagnosis
Stage II
|
5 participants
n=99 Participants
|
|
International Staging System (ISS) Stage of Myeloma on Diagnosis
Stage III
|
2 participants
n=99 Participants
|
|
International Staging System (ISS) Stage of Myeloma on Diagnosis
Unknown
|
1 participants
n=99 Participants
|
|
Monoclonal Protein Type
IgG
|
3 participants
n=99 Participants
|
|
Monoclonal Protein Type
IgA
|
5 participants
n=99 Participants
|
|
Monoclonal Protein Type
Light chain only
|
2 participants
n=99 Participants
|
|
Time to Progression from First Transplant
|
29 months
n=99 Participants
|
|
Time from Diagnosis to V-BEAM transplant
|
42 months
n=99 Participants
|
|
Number of Prior Therapies (including prior transplant)
|
4 prior therapies
n=99 Participants
|
PRIMARY outcome
Timeframe: Day +100Population: Two participants without evaluable responses due to early mortality were not included in this analysis.
Defined by the International Myeloma Working Group (IMWG) criteria
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=8 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Complete Response Rate (Complete Response + Stringent Complete Response)
|
6 participants
|
SECONDARY outcome
Timeframe: Median follow-up of 6 months (range: 6.0-12.0 months)Population: Two participants without evaluable responses due to early mortality were not included in this analysis.
PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission. Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=8 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Number of Participants With Progression-free Survival (PFS)
No relapse/progression
|
7 participants
|
|
Number of Participants With Progression-free Survival (PFS)
Relapse/progression at 12 months
|
1 participants
|
SECONDARY outcome
Timeframe: 3 months following Day +100 visitPopulation: Two participants without evaluable responses due to early mortality were not included in this analysis.
ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR) Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=8 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Overall Response Rate (ORR)
Partial response
|
0 participants
|
|
Overall Response Rate (ORR)
Very good partial response
|
2 participants
|
|
Overall Response Rate (ORR)
Complete response
|
6 participants
|
SECONDARY outcome
Timeframe: Day +100Population: Two participants without evaluable responses due to early mortality were not included in this analysis.
Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=8 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Very Good Partial Response Rate (VGPR+nCR+sCR+CR)
|
8 participants
|
SECONDARY outcome
Timeframe: 30 days after end of treatment / Day +100Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100. This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details.
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=10 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Toxicity of V-BEAM
Neutropenic fever
|
10 participants
|
|
Toxicity of V-BEAM
Clostridium difficile colitis
|
3 participants
|
|
Toxicity of V-BEAM
Neutropenic colitis without Clostridium difficile
|
3 participants
|
|
Toxicity of V-BEAM
Sepsis
|
3 participants
|
|
Toxicity of V-BEAM
Mucositis (grade 1-2)
|
8 participants
|
|
Toxicity of V-BEAM
Mucositis (grade 3-4)
|
2 participants
|
|
Toxicity of V-BEAM
Diarrhea (grade 3-4)
|
10 participants
|
|
Toxicity of V-BEAM
Hepatic toxicity (grade 3-4)
|
1 participants
|
|
Toxicity of V-BEAM
Peripheral neuropathy (grade 1-2)
|
2 participants
|
|
Toxicity of V-BEAM
Toxic death
|
2 participants
|
SECONDARY outcome
Timeframe: Day +100Population: Two participants without evaluable responses due to early mortality were not included in this analysis.
Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC \> 0.5x109/L post transplant when it is sustained for more than three consecutive days.
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=8 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Time to Neutrophil Engraftment After V-BEAM.
|
10 days
Interval 9.0 to 11.0
|
SECONDARY outcome
Timeframe: Median follow-up of 6 months (range: 6-12 months)OS is defined as the duration from the time of transplant to death or last follow-up.
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=10 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Number of Participants With Overall Survival (OS)
Expired Day +3
|
1 participants
|
|
Number of Participants With Overall Survival (OS)
Expired Day +18
|
1 participants
|
|
Number of Participants With Overall Survival (OS)
Alive
|
8 participants
|
SECONDARY outcome
Timeframe: Day +100Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=10 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Treatment Related Mortality (TRM) of V-BEAM
|
2 participants
|
SECONDARY outcome
Timeframe: Day +100Population: Two participants without evaluable responses due to early mortality were not included in this analysis.
Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at \> 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.
Outcome measures
| Measure |
V-BEAM + Stem Cell Infusion
n=8 Participants
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Time to Platelet Engraftment After V-BEAM.
More than 20 x 10^9/L
|
22.5 days
Interval 17.0 to 36.0
|
|
Time to Platelet Engraftment After V-BEAM.
More than 50 x 10^9/L
|
23 days
Interval 17.0 to 46.0
|
Adverse Events
V-BEAM + Stem Cell Infusion
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V-BEAM + Stem Cell Infusion
n=10 participants at risk
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Febrile neutropenia
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
General disorders
Multi-organ failure
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Sepsis (death)
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
Other adverse events
| Measure |
V-BEAM + Stem Cell Infusion
n=10 participants at risk
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Acute gout attack
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Renal and urinary disorders
Acute kidney injury
|
40.0%
4/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
10/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
Blood bilirubin increased
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Metabolism and nutrition disorders
Cachexia
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Clostridium difficile positive colitis
|
30.0%
3/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
Creatinine increased
|
40.0%
4/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Gastrointestinal disorders
Diarrhea
|
90.0%
9/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
General disorders
Edema - limbs
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Gastrointestinal disorders
Enterocolitis
|
30.0%
3/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Esophageal infection
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Febrile neutropenia
|
90.0%
9/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Group B strep bacteremia
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.0%
3/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
70.0%
7/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
5/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
10/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Vascular disorders
Hypotension
|
30.0%
3/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
5/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
10/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Gastrointestinal disorders
Mucositis - oral
|
100.0%
10/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
Neutrophil count decreased
|
100.0%
10/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
Platelet count decreased
|
100.0%
10/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Skin and subcutaneous tissue disorders
Rash (maculo-papular)
|
20.0%
2/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Cardiac disorders
Supraventricular tachycardia
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Gastrointestinal disorders
Typhlitis
|
10.0%
1/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
|
Investigations
White blood cell decreased
|
100.0%
10/10 • Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
|
Additional Information
Ravi Vij, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place