Trial Outcomes & Findings for Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma. (NCT NCT00325416)
NCT ID: NCT00325416
Last Updated: 2018-03-14
Results Overview
MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m\^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (\> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety. Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
COMPLETED
PHASE1/PHASE2
177 participants
Phase I - 5 years, 2 months
2018-03-14
Participant Flow
Phase I: 129 (70 Group A and 60 Group B) participants were enrolled during the Phase I portion. Phase II: 48 (40 Group A and 8 Group B) participants were enrolled during the Phase II portion. Both Phases: 72 Phase I participants were still on study when Phase II began.
Participant milestones
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
|---|---|---|
|
Phase I: Dose Escalation
STARTED
|
70
|
60
|
|
Phase I: Dose Escalation
COMPLETED
|
48
|
44
|
|
Phase I: Dose Escalation
NOT COMPLETED
|
22
|
16
|
|
Phase II: Treatment at MTD
STARTED
|
78
|
42
|
|
Phase II: Treatment at MTD
Proceeded From Phase I to Phase II
|
38
|
34
|
|
Phase II: Treatment at MTD
Enrolled During Phase II
|
40
|
8
|
|
Phase II: Treatment at MTD
COMPLETED
|
78
|
40
|
|
Phase II: Treatment at MTD
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
|---|---|---|
|
Phase I: Dose Escalation
Pre-transplant screen failure
|
8
|
9
|
|
Phase I: Dose Escalation
Denial of insurance coverage
|
7
|
4
|
|
Phase I: Dose Escalation
Withdrawal by Subject
|
7
|
2
|
|
Phase I: Dose Escalation
Inability to collect adequate stem cells
|
0
|
1
|
|
Phase II: Treatment at MTD
denial of insurance coverage
|
0
|
1
|
|
Phase II: Treatment at MTD
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.
Baseline characteristics by cohort
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
n=109 Participants
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
n=68 Participants
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
68.5 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=5 Participants
|
68 participants
n=7 Participants
|
177 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase I - 5 years, 2 monthsPopulation: Phase I Dose Escalation participants.
MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m\^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (\> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety. Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Outcome measures
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
n=69 Participants
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
n=60 Participants
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
|---|---|---|
|
Phase I - Maximum Tolerated Dose (MTD) Level
|
127.8 mg/m^2
|
30 mg/m^2
|
PRIMARY outcome
Timeframe: Phase II - Phase start at 62 months up to 120 monthsPopulation: Phase II (treatment at MTD) participants with responsive disease prior to transplant.
Re-evaluation of participants who had responsive disease prior to transplant. All changes in monoclonal protein and immunoglobulins will be referenced to those levels obtained immediately prior to cyclophosphamide priming chemotherapy. Complete Response (CR): A CR will be defined as the disappearance of the monoclonal protein by immunofixation studies of serum and urine (100x concentrate) and less than or equal to 5% plasma cells in a bone marrow aspirate. Partial Response (PR): 50% - 74% decrease in the measurable monoclonal protein (M-component from an SPEP and/or UPEP with immunofixation).
Outcome measures
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
n=23 Participants
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
n=28 Participants
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
|---|---|---|
|
Phase II Participants - Overall Response Rate
Overall Response Rate
|
65 percentage of participants
|
57 percentage of participants
|
|
Phase II Participants - Overall Response Rate
Complete Response Rate
|
26 percentage of participants
|
18 percentage of participants
|
|
Phase II Participants - Overall Response Rate
Partial Response Rate
|
39 percentage of participants
|
39 percentage of participants
|
SECONDARY outcome
Timeframe: Phase II - Phase start at 62 months up to 120 monthsPopulation: Phase II (treatment at MTD) evaluable participants at time of analysis
Time to treatment failure, which is defined as the time from day 0 to the time of progressive disease. Progressive disease is defined by unequivocal objective evidence and constitutes any of the following: 1). an increase in the total amount of monoclonal protein (M-component from Serum Protein Electrophoresis (SPEP) and/or Urine Protein Electrophoresis (UPEP) with immunofixation) by more than 100% from the lowest level of serum myeloma protein seen after high-dose chemotherapy by serum protein electrophoresis; 2). an increase in the total amount of monoclonal protein above the remission level of the myeloma peak (i.e., an increase of \>25% above the lowest level in a 24 hour urine or serum protein; 3). the reappearance of the M-protein if the patient had entered a CR: 4). definite increase in the size (\> 1 cm) or number of lytic bone lesions. Compression fractures do not constitute a relapse.
Outcome measures
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
n=39 Participants
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
n=40 Participants
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
|---|---|---|
|
Phase II Event Free Survival (EFS)
|
13.3 months
Interval 11.6 to 21.5
|
21.3 months
Interval 14.9 to 27.2
|
SECONDARY outcome
Timeframe: Phase II - Phase start at 62 months up to 120 monthsPopulation: Phase II (treatment at MTD) evaluable participants at time of analysis
Time from start of treatment until death from any cause.
Outcome measures
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
n=39 Participants
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
n=40 Participants
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
|---|---|---|
|
Phase II Overall Survival (OS)
|
63 months
Interval 35.0 to
not yet reached
|
62 months
Interval 45.0 to
not yet reached
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Predetermined time points in protocolEvaluate the pharmacokinetic profiles of high dose topotecan and melphalan and to investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in each age group. Pharmacokinetics of Topotecan: For all dose levels, topotecan levels on Day -4 will be obtained at -15 min, 20 min into 30 min infusion, and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, and 23 h after the 30 min infusion. Pharmacokinetics of Melphalan: For all dose levels, melphalan levels during the first day of cytoxan priming chemotherapy and on Day -4 will be obtained before, at the end of the infusion, and 5 minutes (min), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min and 180 min after the infusion. The infusion time for the test dose of melphalan is over 5 min and for the high-dose is over 30 min.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Laboratory study (no specific time points)Laboratory Correlates will be summarized using descriptive statistics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Laboratory study (N/A)Laboratory Correlates will be summarized using descriptive statistics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Laboratory study (N/A)Laboratory Correlates will be summarized using descriptive statistics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Laboratory study (N/A)BCRP function will be assayed in multiple myeloma patient bone marrow aspirates obtained before and during high dose chemotherapy. BCRP function is expressed as the change in relative fluorescence in topotecan versus control cells. The distribution of paired differences in BCRP, a continuous variable, will be summarized using descriptive statistics and will be correlated with response and toxicity.
Outcome measures
Outcome data not reported
Adverse Events
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
Serious adverse events
| Measure |
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
n=109 participants at risk
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
n=68 participants at risk
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes - low
|
0.92%
1/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Blood and lymphatic system disorders
Platelets - low
|
0.92%
1/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
1.8%
2/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
10.1%
11/109 • 10 years
|
10.3%
7/68 • 10 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
4/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Gastrointestinal disorders
Nausea
|
5.5%
6/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
3/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Infections and infestations
Infection - Other - cellulitis
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Metabolism and nutrition disorders
ALT, SGPT 9serum glutamic pyruvic transaminase) - increased
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase) - increased
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Metabolism and nutrition disorders
Alkaline phosphatase - increased
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.92%
1/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other - Knee
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other - Rotator cuff
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Nervous system disorders
Neuropathy: motor
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Nervous system disorders
Neuropathy: sensory
|
1.8%
2/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
General disorders
Pain - Back
|
1.8%
2/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
General disorders
Pain - Bone
|
1.8%
2/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Cardiac disorders
Hypertension
|
0.92%
1/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Ear and labyrinth disorders
Blurred vision
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Eye disorders
Eye - NOS (visual changes)
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
General disorders
Fatigue
|
2.8%
3/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Infections and infestations
Febrile neutropenia
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.3%
8/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Cardiac disorders
Symptomatic pericarditis
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Infections and infestations
Infection: Catheter related
|
1.8%
2/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Cardiac disorders
Hypotension
|
3.7%
4/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
General disorders
Pain - Chest wall
|
4.6%
5/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Infections and infestations
Infection - Other - Sepsis syndrome
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
General disorders
Rigors/chills
|
2.8%
3/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Psychiatric disorders
Hallucinations
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
3/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Blood and lymphatic system disorders
Hemoglobin - low
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
1.8%
2/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Infections and infestations
Infection - Lung (pneumonia)
|
3.7%
4/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
General disorders
Pain - Head/headache
|
3.7%
4/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Infections and infestations
Infections and infestations - Other - Herpes Zoster
|
0.92%
1/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Infections and infestations
Infection- Other - CMV Viremia
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Infections and infestations
Infection - Other - Residual enteritis
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Psychiatric disorders
Anxiety
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Investigations
Weight loss
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
General disorders
Pain - Extremity - limb
|
0.92%
1/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Psychiatric disorders
Confusion
|
0.92%
1/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Vascular disorders
Flushing
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other - decreased urine output
|
0.00%
0/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Infections and infestations
Infection - Rectum
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Gastrointestinal disorders
Constipation
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Eye disorders
Photophobia
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Psychiatric disorders
Psychiatric disorders - Other - mental status change
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/109 • 10 years
|
2.9%
2/68 • 10 years
|
|
Renal and urinary disorders
Creatinine - high
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Infections and infestations
Infection - Sinus
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
General disorders
Wound
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
|
Nervous system disorders
Dizziness
|
0.92%
1/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
Renal and urinary disorders
Hematuria
|
1.8%
2/109 • 10 years
|
0.00%
0/68 • 10 years
|
|
General disorders
Death, NOS
|
0.00%
0/109 • 10 years
|
1.5%
1/68 • 10 years
|
Other adverse events
Adverse event data not reported
Additional Information
Daniel M. Sullivan, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place