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AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia (AMD3100+MEC)

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ClinicalTrials.gov Identifier: NCT00512252
Recruitment Status : Completed
First Posted : August 7, 2007
Results First Posted : September 22, 2014
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Myeloid, Acute
Interventions Drug: AMD3100
Drug: Mitoxantrone
Drug: Etoposide
Drug: Cytarabine
Enrollment 52
Recruitment Details Recruitment occurred from 07/12/2007 until 01/14/2010.
Pre-assignment Details  
Arm/Group Title Phase I Dose Escalation (Dose Level 1) Phase I Dose Escalation (Dose Level 2) Phase II Dose Treatment (Dose Level 3)
Hide Arm/Group Description
  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 1 AMD3100 dose = 80 mcg/kg/d

  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 2 AMD3100 dose = 160 mcg/kg/d

  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).

The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.

Period Title: Overall Study
Started 3 3 46
Completed 3 3 43
Not Completed 0 0 3
Reason Not Completed
Lost to Follow-up             0             0             1
Protocol Violation             0             0             1
Death             0             0             1
Arm/Group Title Phase I Dose Escalation (Dose Level 1) Phase I Dose Escalation (Dose Level 2) Phase II Dose Treatment (Dose Level 3) Total
Hide Arm/Group Description
  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 1 AMD3100 dose = 80 mcg/kg/d

  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 2 AMD3100 dose = 160 mcg/kg/d

  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).

The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.

Total of all reporting groups
Overall Number of Baseline Participants 3 3 46 52
Hide Baseline Analysis Population Description
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 46 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
1
   2.2%
1
   1.9%
Between 18 and 65 years
3
 100.0%
3
 100.0%
40
  87.0%
46
  88.5%
>=65 years
0
   0.0%
0
   0.0%
5
  10.9%
5
   9.6%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 46 participants 52 participants
58
(44 to 62)
24
(22 to 39)
51
(18 to 71)
51
(18 to 71)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 46 participants 52 participants
Female
2
  66.7%
2
  66.7%
26
  56.5%
30
  57.7%
Male
1
  33.3%
1
  33.3%
20
  43.5%
22
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 46 participants 52 participants
3 3 46 52
Acute myeloid leukemia (AML) source   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 46 participants 52 participants
De novo AML 3 2 36 41
Therapy related 0 1 4 5
Prior MDS/MPD 0 0 6 6
[1]
Measure Description: MDS = myelodysplastic syndrome MPD = myeloproliferative disease
Prior transplantation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 46 participants 52 participants
Autologous 0 0 3 3
Allogeneic 0 0 6 6
No prior transplant 3 3 37 43
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 46 participants 52 participants
0 2 2 25 29
1 1 1 10 12
2 0 0 3 3
Unknown 0 0 8 8
[1]
Measure Description:

Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 Fully active able to carry on all predisease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (light house work/office work)
  2. Ambulatory, capable of all selfcare but unable to carry out any work activities. Up & about more than 50% of waking hours
  3. Capable of limited selfcare, confined to bed/chair more than 50% of waking hours
  4. Completely disabled. Cannot carry on selfcare. Totally confined to bed/chair
  5. Dead
Treatment Indication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 46 participants 52 participants
First relapse, first salvage 3 2 32 37
Primary refractory 0 1 10 11
>=Second relapse/salvage 0 0 4 4
1.Primary Outcome
Title Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML
Hide Description A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 <= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.
Time Frame Completion of all patients in Phase I portion (232 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The Phase I Dose Escalation portion included (3) patients enrolled in Dose Level 1 and (3) patients enrolled in Dose Level 2. The (6) patients enrolled in Dose Level 3 that determined the Phase II dose are included in the population for this outcome.
Arm/Group Title Phase I Dose Escalation
Hide Arm/Group Description:
  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 1 AMD3100 dose = 80 mcg/kg/d

Dose Level 2 AMD3100 dose = 160 mcg/kg/d

Dose Level 3 AMD3100 dose = 240 mcg/kg/d

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: mcg/kg
240
2.Primary Outcome
Title Phase II Only: Complete Response Rate of AMD3100 + MEC
Hide Description

Responses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response.

Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi).

Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Relapse, First Salvage Primary Refractory >= Second Relapse/Salvage Total
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Phase II Dose Patients
Overall Number of Participants Analyzed 32 10 4 46
Measure Type: Number
Unit of Measure: percentage of participants
CR + CRi 56 20 25 46
CR only 47 20 25 39
3.Primary Outcome
Title Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions
Hide Description [Not Specified]
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not analyzed as data was not collected.
Arm/Group Title Phase I Dose Escalation/Phase II Dose Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Safety and Tolerability of AMD3100 + MEC.
Hide Description Treatment related mortality (deaths occurring during treatment)
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
The 46 patients include the 6 patients treated on Dose Level 3 of the Phase I portion of the study.
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
Sepsis 2
Adverse transfusion reaction w/febrile neutropenia 1
5.Secondary Outcome
Title Time to Neutrophil Recovery
Hide Description Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count >1,000 cells/mm^3.
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes patients who achieved a CR or a CRi.
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)

Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: days
28
(21 to 46)
6.Secondary Outcome
Title Time to Platelet Recovery
Hide Description Defined as the date of the first dose of AMD3100 to the date that the platelet count is >100,000/mm3 in the absence of platelet transfusions.
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes patients who achieved a CR.
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)

Overall Number of Participants Analyzed 18
Median (Full Range)
Unit of Measure: days
28.5
(16 to 42)
7.Secondary Outcome
Title Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Hide Description

Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.

Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC.

Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I Dose Escalation - Dose Level 1 Phase I Dose Escalation - Dose Level 2 Phase I Dose Escalation - Dose Level 3
Hide Arm/Group Description:
  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 1 AMD3100 dose = 80 mcg/kg/d

  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 2 AMD3100 dose = 160 mcg/kg/d

  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose = 240 mcg/kg/d

Overall Number of Participants Analyzed 3 3 6
Median (Full Range)
Unit of Measure: cells x 10^3/microliter
Total leukocytes at 0 hours
2.5
(1.9 to 3.0)
4.7
(2.9 to 6.1)
3.5
(1.2 to 16.5)
Total leukocytes at 1 hour
4.3
(2.7 to 6.9)
7.0
(3.9 to 10.8)
6.4
(3.4 to 24.5)
Total leukocytes at 2 hours
4
(3.2 to 7.9)
8.5
(3.7 to 11.3)
7.5
(2.0 to 27.0)
Total leukocytes at 4 hours
4.7
(3.4 to 10.8)
9.4
(3.8 to 12.1)
8.3
(2.0 to 38.6)
Total leukocytes at 6 hours
4.8
(3.9 to 17.0)
11.3
(4.3 to 14.3)
9.5
(2.1 to 32)
Total leukocytes at 8 hours
4.5
(3.6 to 11.5)
12.0
(4.4 to 16.3)
8.9
(2.3 to 39.0)
Total leukocytes at 12 hours
5.1
(2.8 to 13.2)
12.1
(5.1 to 16.0)
7.8
(2.0 to 38.9)
Total leukocytes at 24 hours
4.3
(1.7 to 8.1)
7.9
(3.4 to 11.7)
5.8
(1.5 to 22.2)
8.Secondary Outcome
Title Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
Hide Description Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I Dose Escalation - Dose Level 1 Phase I Dose Escalation - Dose Level 2 Phase I Dose Escalation - Dose Level 3
Hide Arm/Group Description:
  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 1 AMD3100 dose = 80 mcg/kg/d

  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 2 AMD3100 dose = 160 mcg/kg/d

  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose = 240 mcg/kg/d

Overall Number of Participants Analyzed 3 3 6
Median (Full Range)
Unit of Measure: percentage of AML blasts
AML blasts at 0 hours
46.0
(2.0 to 54.0)
4.0 [1] 
(NA to NA)
43.5
(10.0 to 77.0)
AML blasts at 1 hour
26.0
(5.0 to 34.0)
9.0 [1] 
(NA to NA)
30.5
(9.0 to 68.0)
AML blasts at 2 hours
26.0
(3.0 to 40.0)
37.5
(3.0 to 72.0)
32.5
(5.0 to 67.0)
AML blasts at 4 hours
37.0
(4.0 to 46.0)
16.0
(1.0 to 64.0)
30.0
(4.0 to 60.0)
AML blasts at 6 hours
31.0
(2.0 to 53.0)
14.0
(2.0 to 63.0)
27.0
(9.0 to 74.0)
AML blasts at 8 hours
32.0
(5.0 to 52.0)
19.0
(6.0 to 67.0)
26.0
(8.0 to 70.0)
AML blasts at 12 hours
27.0
(2.0 to 30.0)
45.0
(21 to 69)
35.0
(14.0 to 82.0)
AML blasts at 24 hours
35.0
(3.0 to 52.0)
23
(13 to 33)
55
(12 to 68)
[1]
The AML blasts at 0 hour was not performed on 2 out of the 3 patients.
9.Secondary Outcome
Title Pharmacokinetics of AMD3100 on MEC
Hide Description [Not Specified]
Time Frame Day 1 - Phase 2 only
Hide Outcome Measure Data
Hide Analysis Population Description
This was not performed.
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame Every 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not analyzed instead "reason for treatment failure" was analyzed as it provided better information on why the treatment did not work.
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Treatment Failure
Hide Description Treatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi.
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Relapse, First Salvage Primary Refractory >= Second Relapse/Salvage Total
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Phase II Dose Patients
Overall Number of Participants Analyzed 14 8 3 25
Measure Type: Number
Unit of Measure: participants
Persistent leukemia 12 6 3 21
Death during aplasia 1 2 0 3
Unknown 1 0 0 1
12.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of participants
37
13.Secondary Outcome
Title Relapse-free Survival
Hide Description

This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause.

Kaplain-Meier estimate was used.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
This excludes the 25 participants who had treatment failure.
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of participants
42.9
Time Frame Adverse event assessment was collected from start of treatment for 42 days
Adverse Event Reporting Description The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
 
Arm/Group Title Phase I Dose Escalation (Dose Level 1) Phase I Dose Escalation (Dose Level 2) Phase II Dose Treatment (Dose Level 3)
Hide Arm/Group Description
  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 1 AMD3100 dose = 80 mcg/kg/d

  • AMD3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 2 AMD3100 dose = 160 mcg/kg/d

  • AMD 3100 SQ on days 0-5
  • Mitoxantrone on days 1-5
  • Etoposide on days 1-5
  • Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).

The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.

All-Cause Mortality
Phase I Dose Escalation (Dose Level 1) Phase I Dose Escalation (Dose Level 2) Phase II Dose Treatment (Dose Level 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I Dose Escalation (Dose Level 1) Phase I Dose Escalation (Dose Level 2) Phase II Dose Treatment (Dose Level 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   3/46 (6.52%) 
Cardiac disorders       
Hypotension  1 [1]  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Immune system disorders       
Allergic reaction - platelet transfusion  1 [2]  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Infections and infestations       
Infection-other (gram negative sepsis)  1 [3]  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Unrelated
[2]
Grade 5 - unlikely related
[3]
Grade 5 unrelated
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I Dose Escalation (Dose Level 1) Phase I Dose Escalation (Dose Level 2) Phase II Dose Treatment (Dose Level 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   46/46 (100.00%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  3/3 (100.00%)  3/3 (100.00%)  31/46 (67.39%) 
Cardiac disorders       
Atrial fibrillation  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Bradycardia  1  0/3 (0.00%)  2/3 (66.67%)  8/46 (17.39%) 
Chest pain  1  1/3 (33.33%)  0/3 (0.00%)  4/46 (8.70%) 
Hypertension  1  0/3 (0.00%)  1/3 (33.33%)  11/46 (23.91%) 
Hypotension  1  2/3 (66.67%)  0/3 (0.00%)  10/46 (21.74%) 
Palpitations  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Supraventricular tachycardia  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Tachycardia  1  1/3 (33.33%)  2/3 (66.67%)  29/46 (63.04%) 
Vasovagal episode  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Ear and labyrinth disorders       
Ear pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Right ear pain  1  0/3 (0.00%)  2/3 (66.67%)  1/46 (2.17%) 
Tinnitus  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Eye disorders       
Blurred vison  1  1/3 (33.33%)  0/3 (0.00%)  5/46 (10.87%) 
Hemorrhage - eye  1  1/3 (33.33%)  0/3 (0.00%)  2/46 (4.35%) 
Vision - floaters  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Visual changes  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Gastrointestinal disorders       
Abdominal cramping  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Abdominal pain  1  0/3 (0.00%)  2/3 (66.67%)  10/46 (21.74%) 
Colitis  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Constipation  1  0/3 (0.00%)  2/3 (66.67%)  10/46 (21.74%) 
Diarrhea  1  2/3 (66.67%)  2/3 (66.67%)  26/46 (56.52%) 
Distension  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Dysphagia  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Epigastric pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Esophagus pain  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Heartburn  1  1/3 (33.33%)  1/3 (33.33%)  3/46 (6.52%) 
Hematemesis  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Hemorrhoidal pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Hemorrhoids  1  1/3 (33.33%)  1/3 (33.33%)  1/46 (2.17%) 
Indigestion  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Left lower abdominal pain  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Mucositis (oral and stomach)  1  1/3 (33.33%)  2/3 (66.67%)  33/46 (71.74%) 
Nausea  1  2/3 (66.67%)  3/3 (100.00%)  33/46 (71.74%) 
Perianal pain  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Right upper quadrant pain  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Taste alteration  1  0/3 (0.00%)  0/3 (0.00%)  4/46 (8.70%) 
Vomiting  1  2/3 (66.67%)  3/3 (100.00%)  17/46 (36.96%) 
Weight loss  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
General disorders       
Bilateral extremity echymosis  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Bilateral extremity petichiae  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Chills  1  0/3 (0.00%)  1/3 (33.33%)  6/46 (13.04%) 
Diaphoresis  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Edema face  1  0/3 (0.00%)  0/3 (0.00%)  7/46 (15.22%) 
Edema limbs  1  1/3 (33.33%)  1/3 (33.33%)  17/46 (36.96%) 
Edema trunk  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Fatigue  1  0/3 (0.00%)  2/3 (66.67%)  14/46 (30.43%) 
Fever  1  0/3 (0.00%)  0/3 (0.00%)  4/46 (8.70%) 
Generalized edema  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Generalized pain  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Hematoma  1 [1]  0/3 (0.00%)  0/3 (0.00%)  4/46 (8.70%) 
Hypothermia  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Injection site reaction  1  2/3 (66.67%)  0/3 (0.00%)  7/46 (15.22%) 
Lip swelling  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Petichiae  1  0/3 (0.00%)  0/3 (0.00%)  6/46 (13.04%) 
Tooth pain  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Weakness  1  0/3 (0.00%)  0/3 (0.00%)  0/46 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Hepatomegaly  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Jaundice - right eye  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Immune system disorders       
Allergic reaction - NOS  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Allergic reaction - general itching during transfusion  1  1/3 (33.33%)  1/3 (33.33%)  0/46 (0.00%) 
Allergic reaction - platelet transfusion  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Infections and infestations       
Cellulitis  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Colitis, infectious - clostridium difficile  1  0/3 (0.00%)  0/3 (0.00%)  4/46 (8.70%) 
Infection, gram positive cocci  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Liver abcess  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Nasal/paranasal reactions - sinusitis  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Opportunistic infection (pneumonia NOS)  1  0/3 (0.00%)  1/3 (33.33%)  2/46 (4.35%) 
Opportunistic infection - urinary tract  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Opportunistic infection, nasal  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Perirectal abscess  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Infection - gram negative sepsis  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Infection - gram negative bacilli  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Injury, poisoning and procedural complications       
Bruising  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Incisional pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Injection site pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Lower back wound pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Pilonidal cyst  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Wound - coccyx  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Investigations       
ALT  1  1/3 (33.33%)  0/3 (0.00%)  14/46 (30.43%) 
AST  1  0/3 (0.00%)  1/3 (33.33%)  11/46 (23.91%) 
Alkaline phosphatase  1  0/3 (0.00%)  0/3 (0.00%)  20/46 (43.48%) 
Hemoglobin  1  3/3 (100.00%)  2/3 (66.67%)  17/46 (36.96%) 
Hyperbilirubinemia  1  0/3 (0.00%)  0/3 (0.00%)  7/46 (15.22%) 
Hypernatremia  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Hypoalbuminemia  1  2/3 (66.67%)  3/3 (100.00%)  17/46 (36.96%) 
Hypocalcemia  1  3/3 (100.00%)  1/3 (33.33%)  20/46 (43.48%) 
Hypokalemia  1  2/3 (66.67%)  1/3 (33.33%)  11/46 (23.91%) 
Hyponatremia  1  3/3 (100.00%)  1/3 (33.33%)  7/46 (15.22%) 
Hypophosphatemia  1  2/3 (66.67%)  1/3 (33.33%)  6/46 (13.04%) 
Leukocytes  1  3/3 (100.00%)  3/3 (100.00%)  38/46 (82.61%) 
Lymphopenia  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Neutrophils  1  3/3 (100.00%)  1/3 (33.33%)  21/46 (45.65%) 
Platelets  1  1/3 (33.33%)  2/3 (66.67%)  23/46 (50.00%) 
Metabolism and nutrition disorders       
Anorexia  1  1/3 (33.33%)  2/3 (66.67%)  25/46 (54.35%) 
Hyperkalemia  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Hyperuricemia  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/3 (0.00%)  2/3 (66.67%)  0/46 (0.00%) 
Back pain  1  2/3 (66.67%)  1/3 (33.33%)  8/46 (17.39%) 
Bone marrow biopsy site pain  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Coccyx pain  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Extremity pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Facial pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Flank pain  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Generalized bone pain  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Generalized joint pain  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Hip pain  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Jaw pain  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Left arm pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Left elbow pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Leg pain  1  0/3 (0.00%)  1/3 (33.33%)  2/46 (4.35%) 
Lower extremity pain  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Mouth pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Mouth pain - right side  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Muscle weakness  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Muscle weakness - generalized  1  1/3 (33.33%)  0/3 (0.00%)  24/46 (52.17%) 
Neck pain  1  2/3 (66.67%)  0/3 (0.00%)  3/46 (6.52%) 
Rib pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Right arm pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Right forearm pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Right head and neck pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Right hip pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Right jaw pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Right side pain  1  0/3 (0.00%)  1/3 (33.33%)  1/46 (2.17%) 
Shoulder pain  1  1/3 (33.33%)  0/3 (0.00%)  3/46 (6.52%) 
Nervous system disorders       
Cognitive disturbance - lethargy  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Dizziness  1  0/3 (0.00%)  0/3 (0.00%)  5/46 (10.87%) 
Headache  1  2/3 (66.67%)  3/3 (100.00%)  19/46 (41.30%) 
Neuropathy (not specified)  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Neuropathy - bilateral feet  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Neuropathy - bilateral hands  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Neuropathy - face  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Neuropathy - left eye droop  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Neuropathy - left hand  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Neuropathy - right ankle  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Neuropathy - toes  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Restless leg syndrome  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Pregnancy, puerperium and perinatal conditions       
Red and swollen left labia  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Vaginal bleeding  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Psychiatric disorders       
Agitation  1  2/3 (66.67%)  0/3 (0.00%)  2/46 (4.35%) 
Anxiety  1  2/3 (66.67%)  3/3 (100.00%)  11/46 (23.91%) 
Claustrophobia  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Confusion  1  0/3 (0.00%)  0/3 (0.00%)  5/46 (10.87%) 
Depression  1  0/3 (0.00%)  0/3 (0.00%)  4/46 (8.70%) 
Insomnia  1  0/3 (0.00%)  1/3 (33.33%)  14/46 (30.43%) 
Mood alteration (not specified)  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Renal and urinary disorders       
Bladder spasms  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Catheter site insertion pain  1  1/3 (33.33%)  1/3 (33.33%)  3/46 (6.52%) 
Dysuria  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Incontinence  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Incontinence - secondary to urinary urgency  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Renal failure  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Urinary frequency  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Urinary hesitancy  1  1/3 (33.33%)  0/3 (0.00%)  1/46 (2.17%) 
Urinary retention  1  1/3 (33.33%)  0/3 (0.00%)  2/46 (4.35%) 
Respiratory, thoracic and mediastinal disorders       
Atelectasis  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Cough  1  1/3 (33.33%)  1/3 (33.33%)  13/46 (28.26%) 
Dyspnea  1  0/3 (0.00%)  1/3 (33.33%)  10/46 (21.74%) 
Hemorrhage - nose  1  1/3 (33.33%)  0/3 (0.00%)  4/46 (8.70%) 
Hiccups  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Hypoxia  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Pain upon inspiration  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Pleural effusion  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Pulmonary edema  1  0/3 (0.00%)  1/3 (33.33%)  0/46 (0.00%) 
Sinus pain  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Sore throat  1  0/3 (0.00%)  0/3 (0.00%)  2/46 (4.35%) 
Tachypnea  1  0/3 (0.00%)  0/3 (0.00%)  4/46 (8.70%) 
Throat pain  1  1/3 (33.33%)  0/3 (0.00%)  6/46 (13.04%) 
Skin and subcutaneous tissue disorders       
Acute febrile neutrophilic dermatosis  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Alopecia  1  1/3 (33.33%)  0/3 (0.00%)  0/46 (0.00%) 
Bumps on legs and arms  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Erythema  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Itching (pruritus)  1  2/3 (66.67%)  0/3 (0.00%)  10/46 (21.74%) 
Rash  1 [2]  2/3 (66.67%)  3/3 (100.00%)  10/46 (21.74%) 
Ulceration  1  0/3 (0.00%)  0/3 (0.00%)  3/46 (6.52%) 
Vascular disorders       
Deep vein thrombosis  1  0/3 (0.00%)  0/3 (0.00%)  1/46 (2.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
right arm and central line placement
[2]
Includes undefined rash, vaginal, lower extremities, left arm, and bilateral arms.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Geoffrey L. Uy, M.D.
Organization: Washington University School of Medicine
Phone: 314-454-8304
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00512252     History of Changes
Other Study ID Numbers: 07-0227 / 201011796
First Submitted: August 6, 2007
First Posted: August 7, 2007
Results First Submitted: July 28, 2014
Results First Posted: September 22, 2014
Last Update Posted: December 12, 2016