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Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis

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ClinicalTrials.gov Identifier: NCT00477971
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : July 21, 2015
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Biological: filgrastim
Drug: dexamethasone
Drug: melphalan
Procedure: autologous hematopoietic stem cell transplantation
Enrollment 89
Recruitment Details From October 2005 to August 2012, 89 participants were recruited.
Pre-assignment Details This study was originally designed as a randomized Phase III clinical trial; however the unwillingness of participants to be randomized to treatment led to changes. The protocol was amended to allow participants to choose between the two regimens.
Arm/Group Title Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Hide Arm/Group Description Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.) Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
Period Title: Overall Study
Started 34 55
Completed 17 49
Not Completed 17 6
Reason Not Completed
Disease progression             6             0
Withdrawal by Subject             3             1
Adverse Event             3             0
Death             2             4
Alternative treatment             3             1
Arm/Group Title Low-Dose Melphalan High-Dose Melphalan + Autologous HSC Total
Hide Arm/Group Description Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.) Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0. Total of all reporting groups
Overall Number of Baseline Participants 34 55 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 55 participants 89 participants
62
(48 to 74)
57
(44 to 73)
59
(44 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 55 participants 89 participants
Female
17
  50.0%
16
  29.1%
33
  37.1%
Male
17
  50.0%
39
  70.9%
56
  62.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 55 participants 89 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.8%
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.8%
1
   1.1%
Black or African American
1
   2.9%
1
   1.8%
2
   2.2%
White
32
  94.1%
51
  92.7%
83
  93.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.9%
1
   1.8%
2
   2.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 55 participants 89 participants
34 55 89
ECOG Performance Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 55 participants 89 participants
0-1 25 50 75
2 9 5 14
[1]
Measure Description: Classifies patients according to their functional impairment. 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
Risk Group   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 55 participants 89 participants
Low 20 38 58
High 14 17 31
[1]
Measure Description:

Low Risk (requires all of the following): 1 or 2 organs involved, Cardiac EF >= 50%, Age <= 65 years, NYHA class 1 or 2, Alkaline phosphatase <= 4 x institutional ULN, cardiac involvement fully compensated or asymptomatic, serum creatinine <= 2.0 mg/dL

High Risk (any one of the following): >2 organs involved, Cardiac EF <50%, Age > 65 years, NYHA class 3, Alkaline phosphatase 4-6 x institutional ULN, symptomatic cardiac involvement, serum creatinine 2.1-3.0 mg/dL

1.Primary Outcome
Title Hematologic Response Rate
Hide Description

Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response.

  • Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
  • Very Good Partial Response (VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.
  • Partial Response (PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels.
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Hide Arm/Group Description:
Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
Overall Number of Participants Analyzed 34 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.9
(37.9 to 72.8)
69.1
(55.2 to 80.9)
2.Secondary Outcome
Title 3 Year Overall Survival
Hide Description Percentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Hide Arm/Group Description:
Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
Overall Number of Participants Analyzed 34 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.8
(44.4 to 77.9)
83.6
(74.7 to 94)
3.Secondary Outcome
Title Organ Response to Treatment
Hide Description

Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.

Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%.

Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Hide Arm/Group Description:
Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
Overall Number of Participants Analyzed 34 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.5
(12.8 to 44.4)
29.1
(17.6 to 42.9)
4.Post-Hoc Outcome
Title 3-Year Progression Free Survival
Hide Description

Percentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method.

Progression is assessed when one of the following occur:

  • reappearance of monoclonal protein by immunofixation,
  • Increase in serum monoclonal paraprotein to >25% above the lowest response level,
  • Increase in urine M-protein to > 25% above the lowest remission value for 24-hour excretion.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Hide Arm/Group Description:
Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
Overall Number of Participants Analyzed 34 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.1
(17.2 to 49.4)
51.7
(39.8 to 67)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Hide Arm/Group Description Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.) Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
All-Cause Mortality
Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/34 (17.65%)      3/55 (5.45%)    
Cardiac disorders     
Atrial fibrillation  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Cardiac disorder  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Myocardial ischemia  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Pericardial effusion  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Ventricular fibrillation  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Upper gastrointestinal hemorrhage  1  0/34 (0.00%)  0 1/55 (1.82%)  1
General disorders     
Disease progression  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Sudden death  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Hepatobiliary disorders     
Hepatic failure  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Infections and infestations     
Pneumonia  1  1/34 (2.94%)  1 1/55 (1.82%)  1
Sepsis  1  1/34 (2.94%)  1 1/55 (1.82%)  1
Investigations     
Blood bilirubin increased  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Creatinine increased  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders     
Ischemia cerebrovascular  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Syncope  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Pleural effusion  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Pneumonitis  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Skin and subcutaneous tissue disorders     
Rash desquamating  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Vascular disorders     
Hypotension  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Thrombosis  1  2/34 (5.88%)  2 1/55 (1.82%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low-Dose Melphalan High-Dose Melphalan + Autologous HSC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/34 (100.00%)      55/55 (100.00%)    
Blood and lymphatic system disorders     
Blood disorder  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Febrile neutropenia  1  0/34 (0.00%)  0 32/55 (58.18%)  33
Hemoglobin decreased  1  17/34 (50.00%)  41 49/55 (89.09%)  63
Hemolysis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Cardiac disorders     
Arrhythmia  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Arrhythmia supraventricular  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Atrial fibrillation  1  0/34 (0.00%)  0 5/55 (9.09%)  7
Left ventricular dysfunction  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Left ventricular failure  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Myocarditis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Restrictive cardiomyopathy  1  1/34 (2.94%)  1 2/55 (3.64%)  3
Sinus tachycardia  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Supraventricular tachycardia  1  0/34 (0.00%)  0 1/55 (1.82%)  2
Ventricular tachycardia  1  0/34 (0.00%)  0 3/55 (5.45%)  3
Eye disorders     
Cataract  1  1/34 (2.94%)  2 0/55 (0.00%)  0
Dry eye syndrome  1  0/34 (0.00%)  0 1/55 (1.82%)  2
Gastrointestinal disorders     
Abdominal pain  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Colitis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Constipation  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Diarrhea  1  6/34 (17.65%)  6 25/55 (45.45%)  27
Dysphagia  1  0/34 (0.00%)  0 12/55 (21.82%)  12
Enteritis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Esophageal pain  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Esophagitis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Gastritis  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Hemorrhoids  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Mucositis oral  1  0/34 (0.00%)  0 4/55 (7.27%)  4
Nausea  1  3/34 (8.82%)  3 32/55 (58.18%)  35
Oesophagoscopy abnormal  1  0/34 (0.00%)  0 3/55 (5.45%)  3
Rectal hemorrhage  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Rectal pain  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Stomach pain  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Upper gastrointestinal hemorrhage  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Vomiting  1  2/34 (5.88%)  2 17/55 (30.91%)  19
General disorders     
Chest pain  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Disease progression  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Edema limbs  1  32/34 (94.12%)  140 48/55 (87.27%)  140
Fatigue  1  33/34 (97.06%)  178 55/55 (100.00%)  197
Fever  1  1/34 (2.94%)  1 8/55 (14.55%)  8
General symptom  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Ill-defined disorder  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Localized edema  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Pain  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Infections and infestations     
Abdominal infection  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Anorectal infection  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Bronchitis  1  2/34 (5.88%)  4 0/55 (0.00%)  0
Esophageal infection  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Gingival infection  1  1/34 (2.94%)  2 0/55 (0.00%)  0
Infection  1  3/34 (8.82%)  5 1/55 (1.82%)  1
Infectious colitis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Infectious meningitis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Joint infection  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Lip infection  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Lymph gland infection  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Nail infection  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Pneumonia  1  5/34 (14.71%)  7 4/55 (7.27%)  5
Sepsis  1  2/34 (5.88%)  2 10/55 (18.18%)  12
Sinusitis  1  1/34 (2.94%)  1 1/55 (1.82%)  1
Skin infection  1  4/34 (11.76%)  4 1/55 (1.82%)  1
Upper aerodigestive tract infection  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Upper respiratory infection  1  5/34 (14.71%)  6 2/55 (3.64%)  2
Urinary tract infection  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Vaginal infection  1  1/34 (2.94%)  2 1/55 (1.82%)  1
Injury, poisoning and procedural complications     
Fracture  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Intraoperative gastrointestinal injury - Appendix  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Intraoperative hepatobiliary injury - Gallbladder  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Investigations     
Alanine aminotransferase increased  1  1/34 (2.94%)  1 5/55 (9.09%)  5
Alkaline phosphatase increased  1  2/34 (5.88%)  2 10/55 (18.18%)  11
Aspartate aminotransferase increased  1  1/34 (2.94%)  1 5/55 (9.09%)  5
Blood bilirubin increased  1  0/34 (0.00%)  0 9/55 (16.36%)  10
Creatine phosphokinase increased  1  0/34 (0.00%)  0 1/55 (1.82%)  2
Creatinine increased  1  6/34 (17.65%)  15 21/55 (38.18%)  33
INR increased  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Leukocyte count decreased  1  9/34 (26.47%)  20 51/55 (92.73%)  56
Lymphocyte count decreased  1  2/34 (5.88%)  4 3/55 (5.45%)  5
Neutrophil count decreased  1  8/34 (23.53%)  18 52/55 (94.55%)  60
Platelet count decreased  1  10/34 (29.41%)  27 52/55 (94.55%)  65
Weight loss  1  13/34 (38.24%)  24 21/55 (38.18%)  26
Metabolism and nutrition disorders     
Anorexia  1  0/34 (0.00%)  0 5/55 (9.09%)  5
Blood glucose increased  1  3/34 (8.82%)  3 3/55 (5.45%)  4
Blood uric acid increased  1  1/34 (2.94%)  2 1/55 (1.82%)  2
Dehydration  1  0/34 (0.00%)  0 31/55 (56.36%)  34
Serum albumin decreased  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Serum calcium decreased  1  0/34 (0.00%)  0 5/55 (9.09%)  5
Serum magnesium decreased  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Serum phosphate decreased  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Serum potassium decreased  1  1/34 (2.94%)  1 9/55 (16.36%)  12
Serum potassium increased  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Serum sodium decreased  1  0/34 (0.00%)  0 11/55 (20.00%)  11
Serum sodium increased  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Tumor lysis syndrome  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Back pain  1  2/34 (5.88%)  3 1/55 (1.82%)  1
Bone pain  1  1/34 (2.94%)  2 2/55 (3.64%)  2
Muscle weakness  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Myalgia  1  1/34 (2.94%)  2 1/55 (1.82%)  1
Neck pain  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy  1  1/34 (2.94%)  1 1/55 (1.82%)  1
Nervous system disorders     
Dizziness  1  1/34 (2.94%)  1 1/55 (1.82%)  1
Dysgeusia  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Headache  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Peripheral sensory neuropathy  1  19/34 (55.88%)  72 21/55 (38.18%)  60
Syncope  1  3/34 (8.82%)  6 4/55 (7.27%)  6
Syncope vasovagal  1  1/34 (2.94%)  1 1/55 (1.82%)  1
Psychiatric disorders     
Confusion  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Depression  1  2/34 (5.88%)  3 0/55 (0.00%)  0
Insomnia  1  2/34 (5.88%)  3 4/55 (7.27%)  4
Psychosis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Renal and urinary disorders     
Proteinuria  1  0/34 (0.00%)  0 1/55 (1.82%)  2
Renal failure  1  4/34 (11.76%)  5 4/55 (7.27%)  5
Urinary retention  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Urogenital disorder  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Reproductive system and breast disorders     
Vaginal inflammation  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnea  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Cough  1  2/34 (5.88%)  2 0/55 (0.00%)  0
Dyspnea  1  6/34 (17.65%)  7 11/55 (20.00%)  14
Epistaxis  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Hiccups  1  0/34 (0.00%)  0 2/55 (3.64%)  2
Hypoxia  1  0/34 (0.00%)  0 8/55 (14.55%)  8
Pharyngolaryngeal pain  1  1/34 (2.94%)  1 0/55 (0.00%)  0
Pleural effusion  1  1/34 (2.94%)  1 7/55 (12.73%)  8
Pneumonitis  1  1/34 (2.94%)  1 6/55 (10.91%)  6
Pulmonary hemorrhage  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Respiratory disorder  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Skin and subcutaneous tissue disorders     
Petechiae  1  1/34 (2.94%)  1 2/55 (3.64%)  2
Rash desquamating  1  1/34 (2.94%)  1 5/55 (9.09%)  6
Skin disorder  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Vascular disorders     
Hematoma  1  0/34 (0.00%)  0 1/55 (1.82%)  1
Hemorrhage  1  1/34 (2.94%)  1 1/55 (1.82%)  1
Hypotension  1  4/34 (11.76%)  4 33/55 (60.00%)  34
Thrombosis  1  1/34 (2.94%)  1 4/55 (7.27%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Morie Gertz
Organization: Mayo Clinic
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00477971     History of Changes
Other Study ID Numbers: CDR0000546745
P30CA015083 ( U.S. NIH Grant/Contract )
MC0482 ( Other Identifier: Mayo Clinic Cancer Center )
1691-05 ( Other Identifier: Mayo Clinic IRB )
NCI-2009-01329 ( Registry Identifier: NCI-CTRP )
First Submitted: May 23, 2007
First Posted: May 24, 2007
Results First Submitted: June 23, 2015
Results First Posted: July 21, 2015
Last Update Posted: May 17, 2016