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Trial record 69 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

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ClinicalTrials.gov Identifier: NCT00083551
Recruitment Status : Completed
First Posted : May 27, 2004
Results First Posted : September 22, 2015
Last Update Posted : November 23, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Thalidomide
Drug: Ara-C
Drug: BCNU
Drug: Cisplatin
Drug: Cytoxan
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Etoposide
Drug: Filgrastim
Drug: Recombinant GM-CSF
Drug: Interferon-alpha-2b
Drug: Melphalan
Drug: Vincristine
Enrollment 668
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Thalidomide No Thalidomide
Hide Arm/Group Description Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance. Patient received no thalidomide during induction, consolidation, and maintenance therapy.
Period Title: Overall Study
Started 323 345
Completed 323 345
Not Completed 0 0
Arm/Group Title Thalidomide No Thalidomide Total
Hide Arm/Group Description Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance. Patient received no thalidomide during induction, consolidation, and maintenance therapy. Total of all reporting groups
Overall Number of Baseline Participants 323 345 668
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 323 participants 345 participants 668 participants
>/= 60 to < 65 years 130 129 259
>/= 65 years 64 72 136
< 60 years 129 144 273
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 323 participants 345 participants 668 participants
Female
137
  42.4%
135
  39.1%
272
  40.7%
Male
186
  57.6%
210
  60.9%
396
  59.3%
1.Primary Outcome
Title Overall Survival
Hide Description Overall Survival at six years after initiating protocol therapy
Time Frame 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thalidomide No Thalidomide
Hide Arm/Group Description:
Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
Patient received no thalidomide during induction, consolidation, and maintenance therapy.
Overall Number of Participants Analyzed 323 345
Measure Type: Number
Unit of Measure: percentage of participants
65 58
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thalidomide No Thalidomide
Hide Arm/Group Description Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance. Patient received no thalidomide during induction, consolidation, and maintenance therapy.
All-Cause Mortality
Thalidomide No Thalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Thalidomide No Thalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   323/323 (100.00%)   345/345 (100.00%) 
Blood and lymphatic system disorders     
Grade 3 Clotting-other  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Prothrombin time increase  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Thrombotic microangiopathy  1/323 (0.31%)  0/345 (0.00%) 
Grade 4 Anemia (HGB)  27/323 (8.36%)  34/345 (9.86%) 
Grade 4 Neutropenia/granulocytopenia  242/323 (74.92%)  259/345 (75.07%) 
Grade 4 Platelet transfusion  1/323 (0.31%)  0/345 (0.00%) 
Grade 4 Thrombocytopenia (PLT)  159/323 (49.23%)  168/345 (48.70%) 
Grade 4 Leukopenia (WBC)  257/323 (79.57%)  279/345 (80.87%) 
Grade 3 Hematuria  5/323 (1.55%)  4/345 (1.16%) 
Grade 4 Hematuria  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Hemorrhage w/3-4 thrombocytopenia  38/323 (11.76%)  37/345 (10.72%) 
Grade 4 Hemorrhage w/3-4 thrombocytopenia  6/323 (1.86%)  10/345 (2.90%) 
Grade 3 Hemorrhage w/o 3-4 thrombocytopenia  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Hemorrhage-other  1/323 (0.31%)  0/345 (0.00%) 
Grade 4 Vaginal bleeding  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Petechiae/purpura  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Melena/GI bleeding  6/323 (1.86%)  9/345 (2.61%) 
Grade 4 Melena/GI bleeding  2/323 (0.62%)  2/345 (0.58%) 
Cardiac disorders     
Grade 3 Arrhythmia, NOS  12/323 (3.72%)  21/345 (6.09%) 
Grade 4 Arrhythmia, NOS  2/323 (0.62%)  2/345 (0.58%) 
Grade 3 Cardiac ischemia/infarction  3/323 (0.93%)  2/345 (0.58%) 
Grade 4 Cardiac ischemia/infarction  2/323 (0.62%)  1/345 (0.29%) 
Grade 3 Cardiovascular-other  7/323 (2.17%)  1/345 (0.29%) 
Grade 4 Cardiovascular-other  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Cerebrovascular ischemia  7/323 (2.17%)  2/345 (0.58%) 
Grade 4 Cerebrovascular ischemia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Conduction abnormality/block  0/323 (0.00%)  1/345 (0.29%) 
Grade 4 Conduction abnormality/block  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Edema  6/323 (1.86%)  4/345 (1.16%) 
Grade 3 Hypertension  7/323 (2.17%)  7/345 (2.03%) 
Grade 3 Hypotension  8/323 (2.48%)  8/345 (2.32%) 
Grade 4 Hypotension  5/323 (1.55%)  0/345 (0.00%) 
Grade 3 LVEF decrease/CHF  0/323 (0.00%)  2/345 (0.58%) 
Grade 3 Nodal/junctional dysrhythmia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Sinus bradycardia  6/323 (1.86%)  2/345 (0.58%) 
Grade 4 Sinus bradycardia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Sinus tachycardia  3/323 (0.93%)  2/345 (0.58%) 
Grade 3 Supraventricular arrhythmia  7/323 (2.17%)  7/345 (2.03%) 
Grade 4 Supraventricular arrhythmia  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Surgery-injury of vein/artery  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Syncope  31/323 (9.60%)  12/345 (3.48%) 
Grade 3 Thrombosis/embolism  69/323 (21.36%)  47/345 (13.62%) 
Grade 4 Thrombosis/embolism  11/323 (3.41%)  3/345 (0.87%) 
Grade 3 Valvular heart disease  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Vasovagal episode  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Ventricular arrhythmia  2/323 (0.62%)  3/345 (0.87%) 
Grade 4 Ventricular arrhythmia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Supra Arrhyth: Atrial Fib.  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Cardiac/heart  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Chest/thorax  0/323 (0.00%)  1/345 (0.29%) 
Ear and labyrinth disorders     
Grade 3 Hearing  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Inner ear - hearing loss  8/323 (2.48%)  0/345 (0.00%) 
Grade 3 Middle ear - hearing loss/otitis  2/323 (0.62%)  1/345 (0.29%) 
Grade 3 Earache  2/323 (0.62%)  0/345 (0.00%) 
Endocrine disorders     
Grade 3 Diabetes  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Endocrine - other  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 SIADH  0/323 (0.00%)  1/345 (0.29%) 
Eye disorders     
Grade 3 Blurred vision  3/323 (0.93%)  2/345 (0.58%) 
Grade 3 Cataract  10/323 (3.10%)  4/345 (1.16%) 
Grade 3 Double vision  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Eye - other  2/323 (0.62%)  1/345 (0.29%) 
Grade 3 Keratitis  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Photophobia  0/323 (0.00%)  1/345 (0.29%) 
Grade 4 Retinopathy  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Eye  0/323 (0.00%)  1/345 (0.29%) 
Gastrointestinal disorders     
Grade 3 Anal incontinence  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Anorexia  94/323 (29.10%)  99/345 (28.70%) 
Grade 4 Anorexia  6/323 (1.86%)  6/345 (1.74%) 
Grade 3 Colitis  8/323 (2.48%)  5/345 (1.45%) 
Grade 4 Colitis  1/323 (0.31%)  7/345 (2.03%) 
Grade 3 Constipation/bowel obstruction  31/323 (9.60%)  17/345 (4.93%) 
Grade 4 Constipation/bowel obstruction  6/323 (1.86%)  8/345 (2.32%) 
Grade 3 Dehydration  4/323 (1.24%)  5/345 (1.45%) 
Grade 3 Diarrhea with colostomy  1/323 (0.31%)  4/345 (1.16%) 
Grade 3 Diarrhea without colostomy  61/323 (18.89%)  80/345 (23.19%) 
Grade 4 Diarrhea without colostomy  8/323 (2.48%)  7/345 (2.03%) 
Grade 3 Dyspepsia/heartburn  3/323 (0.93%)  2/345 (0.58%) 
Grade 3 Esophagitis/dysphagia  26/323 (8.05%)  35/345 (10.14%) 
Grade 4 Esophagitis/dysphagia  10/323 (3.10%)  7/345 (2.03%) 
Grade 3 Dysphagia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 GI Mucositis, NOS  20/323 (6.19%)  10/345 (2.90%) 
Grade 4 GI Mucositis, NOS  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 GI-other  2/323 (0.62%)  6/345 (1.74%) 
Grade 4 GI-other  2/323 (0.62%)  1/345 (0.29%) 
Grade 3 Ileus  0/323 (0.00%)  2/345 (0.58%) 
Grade 3 Mouth Dryness  7/323 (2.17%)  5/345 (1.45%) 
Grade 4 Mouth Dryness  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Nausea  117/323 (36.22%)  118/345 (34.20%) 
Grade 4 Nausea  3/323 (0.93%)  4/345 (1.16%) 
Grade 3 Pancreatitis  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Periodontal  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 RT-GI mucositis, NOS  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Stomatitis/pharyngitis  60/323 (18.58%)  41/345 (11.88%) 
Grade 4 Stomatitis/pharyngitis  7/323 (2.17%)  12/345 (3.48%) 
Grade 3 Vomiting  37/323 (11.46%)  42/345 (12.17%) 
Grade 4 Vomiting  6/323 (1.86%)  8/345 (2.32%) 
General disorders     
Grade 3 Fatigue/malaise/lethargy  130/323 (40.25%)  139/345 (40.29%) 
Grade 4 Fatigue/malaise/lethargy  40/323 (12.38%)  52/345 (15.07%) 
Grade 3 Fever without neutropenia  2/323 (0.62%)  8/345 (2.32%) 
Grade 4 Fever without neutropenia  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Fever, NOS  29/323 (8.98%)  25/345 (7.25%) 
Grade 4 Fever, NOS  2/323 (0.62%)  3/345 (0.87%) 
Grade 3 Flu-like symptoms-other  3/323 (0.93%)  4/345 (1.16%) 
Grade 3 Insomnia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Obesity  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Rigors/chills  0/323 (0.00%)  1/345 (0.29%) 
Grade 4 Sweating  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Weight loss  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Abdominal pain/cramping  10/323 (3.10%)  8/345 (2.32%) 
Grade 4 Abdominal pain/cramping  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Arthralgia  6/323 (1.86%)  8/345 (2.32%) 
Grade 4 Arthralgia  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Bone pain  24/323 (7.43%)  18/345 (5.22%) 
Grade 4 Bone pain  4/323 (1.24%)  4/345 (1.16%) 
Grade 3 Chest pain/not cardio or pleural  2/323 (0.62%)  4/345 (1.16%) 
Grade 3 Extremity/limb  1/323 (0.31%)  2/345 (0.58%) 
Grade 3 Hepatic pain  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Hip-left  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Lower back  1/323 (0.31%)  3/345 (0.87%) 
Grade 3 Neuropathic pain  0/323 (0.00%)  3/345 (0.87%) 
Grade 3 Pain NOS  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Pain/other  53/323 (16.41%)  47/345 (13.62%) 
Grade 4 Pain/other  4/323 (1.24%)  0/345 (0.00%) 
Grade 3 Pelvic  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Pleuritic pain  2/323 (0.62%)  0/345 (0.00%) 
Grade 3 Rectal/perirectal pain  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Rib  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Tumor pain  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Upper Back  6/323 (1.86%)  4/345 (1.16%) 
Grade 3 Failure to engraft  1/323 (0.31%)  2/345 (0.58%) 
Grade 3 Stem cell infusion complication  0/323 (0.00%)  2/345 (0.58%) 
Grade 4 Stem cell infusion complication  1/323 (0.31%)  2/345 (0.58%) 
Grade 3 Syndrome/other  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Thrombosis/embolism  1/323 (0.31%)  2/345 (0.58%) 
Hepatobiliary disorders     
Grade 3 Alkaline phosphatase increase  3/323 (0.93%)  4/345 (1.16%) 
Grade 3 Bilirubin increase  8/323 (2.48%)  9/345 (2.61%) 
Grade 4 Bilirnbin increase  4/323 (1.24%)  2/345 (0.58%) 
Grade 3 Hypoalbuminemia  16/323 (4.95%)  18/345 (5.22%) 
Grade 3 Liver enlargement  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 SGOT (AST) increase  9/323 (2.79%)  7/345 (2.03%) 
Grade 4 SGOT (AST) increase  0/323 (0.00%)  3/345 (0.87%) 
Grade 3 SGPT (ALT) increase  18/323 (5.57%)  19/345 (5.51%) 
Grade 4 SGPT (ALT) increase  1/323 (0.31%)  1/345 (0.29%) 
Immune system disorders     
Grade 3 Allergic/hypersensitivity  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Autoimmune reaction  4/323 (1.24%)  1/345 (0.29%) 
Grade 4 Autoimmune reaction  4/323 (1.24%)  0/345 (0.00%) 
Infections and infestations     
Grade 3 Catheter related infection  11/323 (3.41%)  18/345 (5.22%) 
Grade 3 Ear infection ANC mid ear  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Febrile neutropenia  62/323 (19.20%)  80/345 (23.19%) 
Grade 4 Febrile neutropenia  0/323 (0.00%)  2/345 (0.58%) 
Grade 3 GI infection 3-4 ANC abdomen  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 GI infection 3-4 ANC appendix  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 GI Infection 3-4 ANC tooth  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 GI infection ANC abdomen  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 GU infection ABC UTI  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Infection w/grade 3 or 4 Neutrophils  3/323 (0.93%)  1/345 (0.29%) 
Grade 3 Infection w/o 3-4 Neutropenia  29/323 (8.98%)  38/345 (11.01%) 
Grade 4 Infection w/o 3-4 Neutropenia  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Infection w/3-4 Neutropenia  28/323 (8.67%)  27/345 (7.83%) 
Grade 4 Infection w/3-4 Neutropenia  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Infection ANC  27/323 (8.36%)  25/345 (7.25%) 
Grade 4 Infection ANC  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Lung infection 3-4 ANC  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Lung Infection ANC Bronchus  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Lung Infection ANC Lung  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Lung Infection ANC Pharynx  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Moderate  1/323 (0.31%)  2/345 (0.58%) 
Grade 3 Respiratory infect w/neutrop  4/323 (1.24%)  2/345 (0.58%) 
Grade 3 Muscle infection ANC Bone  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Respiratory infection w/o neutrop  17/323 (5.26%)  10/345 (2.90%) 
Grade 4 Respiratory infection w/o neutrop  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Respiratory infection ANC  18/323 (5.57%)  11/345 (3.19%) 
Grade 3 Skin infection 3-4 ANC lip/perior  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Surgery-wound infection  2/323 (0.62%)  0/345 (0.00%) 
Grade 4 Surgery -wound infection  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Urinary tract infectiob w/neutrop  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Uninary tract infection w/o neutrop  1/323 (0.31%)  2/345 (0.58%) 
Grade 4 Urinary tract infection w/o neutrop  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Urinary tract infection ANC  2/323 (0.62%)  3/345 (0.87%) 
Metabolism and nutrition disorders     
Grade 3 Bicarbonate decrease  8/323 (2.48%)  5/345 (1.45%) 
Grade 4 Bicarbonate decrease  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Hypercalcemia  2/323 (0.62%)  4/345 (1.16%) 
Grade 4 Hypercalcemia  6/323 (1.86%)  2/345 (0.58%) 
Grade 3 Hyperglycemia  57/323 (17.65%)  84/345 (24.35%) 
Grade 4 Hyperglycemia  10/323 (3.10%)  10/345 (2.90%) 
Grade 3 Hyperkalemia  11/323 (3.41%)  18/345 (5.22%) 
Grade 4 Hyperkalemia  5/323 (1.55%)  3/345 (0.87%) 
Grade 3 Hypermagnesemia  14/323 (4.33%)  21/345 (6.09%) 
Grade 4 Hypermagnesemia  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Hypermatremia  0/323 (0.00%)  2/345 (0.58%) 
Grade 4 Hyperuricemia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Hypocalcemia  61/323 (18.89%)  75/345 (21.74%) 
Grade 4 Hypocalcemia  20/323 (6.19%)  17/345 (4.93%) 
Grade 3 Hypokalemia  72/323 (22.29%)  89/345 (25.80%) 
Grade 4 Hypokalemia  6/323 (1.86%)  3/345 (0.87%) 
Grade 3 Hypomagnesemia  0/323 (0.00%)  10/345 (2.90%) 
Grade 4 Hypomagnesemia  2/323 (0.62%)  0/345 (0.00%) 
Grade 3 Hyponatremia  101/323 (31.27%)  95/345 (27.54%) 
Grade 4 Hyponatremia  14/323 (4.33%)  8/345 (2.32%) 
Grade 3 Hypophosphatemia  183/323 (56.66%)  214/345 (62.03%) 
Grade 4 Hypophosphatemia  0/323 (0.00%)  3/345 (0.87%) 
Musculoskeletal and connective tissue disorders     
Grade 3 Fracture  0/323 (0.00%)  1/345 (0.29%) 
Grade 2 Gait/Walking  3/323 (0.93%)  0/345 (0.00%) 
Grade 4 Gait/Walking  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Joint, muscle, bone  19/323 (5.88%)  6/345 (1.74%) 
Grade 3 Muscle weakness  6/323 (1.86%)  5/345 (1.45%) 
Grade 3 Osteonecrosis  2/323 (0.62%)  2/345 (0.58%) 
Grade 3 Muscle  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Myalgia  5/323 (1.55%)  2/345 (0.58%) 
Grade 3 Myalgia/arthralgia  0/323 (0.00%)  3/345 (0.87%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Grade 4 Second primary  6/323 (1.86%)  6/345 (1.74%) 
Nervous system disorders     
Grade 3 Apnea  2/323 (0.62%)  0/345 (0.00%) 
Grade 4 Apnea  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Anxiety/agitation  8/323 (2.48%)  16/345 (4.64%) 
Grade 4 Anxiety/agitation  3/323 (0.93%)  5/345 (1.45%) 
Grade 3 Ataxia  10/323 (3.10%)  6/345 (1.74%) 
Grade 4 CNS ischemia  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Confusion  25/323 (7.74%)  23/345 (6.67%) 
Grade 4 Confusion  5/323 (1.55%)  8/345 (2.32%) 
Grade 3 Depression  32/323 (9.91%)  28/345 (8.12%) 
Grade 4 Depression  6/323 (1.86%)  6/345 (1.74%) 
Grade 3 Dizziness/light headedness  35/323 (10.84%)  15/345 (4.35%) 
Grade 4 Dizziness/light headedness  4/323 (1.24%)  3/345 (0.87%) 
Grade 3 Dizziness/vertigo  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Hallucinations  4/323 (1.24%)  2/345 (0.58%) 
Grade 3 Headache  11/323 (3.41%)  19/345 (5.51%) 
Grade 3 Insomnia  4/323 (1.24%)  4/345 (1.16%) 
Grade 3 Involuntary movement/restlessnes  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Mood/consciousness change  23/323 (7.12%)  17/345 (4.93%) 
Grade 4 Mood/consciousness change  2/323 (0.62%)  3/345 (0.87%) 
Grade 3 Neuro-other  3/323 (0.93%)  3/345 (0.87%) 
Grade 4 Neuro-other  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Seizures  2/323 (0.62%)  1/345 (0.29%) 
Grade 4 Seizures  0/323 (0.00%)  3/345 (0.87%) 
Grade 3 Sensory/neuropathy  46/323 (14.24%)  13/345 (3.77%) 
Grade 4 Sensory/neuropathy  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Somnolence/consciousness loss  40/323 (12.38%)  32/345 (9.28%) 
Grade 4 Somnolence/consciousness loss  4/323 (1.24%)  4/345 (1.16%) 
Grade 3 Speech impairment  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Tremor  32/323 (9.91%)  15/345 (4.35%) 
Grade4 Tremor  2/323 (0.62%)  1/345 (0.29%) 
Grade 3 Weakness (motor neuropathy)  55/323 (17.03%)  36/345 (10.43%) 
Grade 4 Weakness (motor neuropathy)  3/323 (0.93%)  5/345 (1.45%) 
Renal and urinary disorders     
Grade 3 Bladder Spasms  4/323 (1.24%)  2/345 (0.58%) 
Grade 4 Bladder Spasms  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Creatinine increase  12/323 (3.72%)  8/345 (2.32%) 
Grade 4 Creatinine increase  16/323 (4.95%)  15/345 (4.35%) 
Grade 3 GU-other  2/323 (0.62%)  1/345 (0.29%) 
Grade 3 incontinence  0/323 (0.00%)  1/345 (0.29%) 
Grade 3 Renal failure  6/323 (1.86%)  6/345 (1.74%) 
Grade 4 Renal failure  8/323 (2.48%)  5/345 (1.45%) 
Grade 3 Urinary frequency/urgency  0/323 (0.00%)  2/345 (0.58%) 
Grade 3 Urinary retention  1/323 (0.31%)  0/345 (0.00%) 
Reproductive system and breast disorders     
Grade 3 Erectile impotence  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Female sterility  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Menses changes  1/323 (0.31%)  0/345 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Grade 4 Acute respiratory distress syndrome  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Cough  6/323 (1.86%)  3/345 (0.87%) 
Grade 3 Dyspnea  18/323 (5.57%)  12/345 (3.48%) 
Grade 4 Dyspnea  3/323 (0.93%)  1/345 (0.29%) 
Grade 3 Hiccoughs  2/323 (0.62%)  2/345 (0.58%) 
Grade 3 Hypoxia  33/323 (10.22%)  37/345 (10.72%) 
Grade 4 Hypoxia  7/323 (2.17%)  3/345 (0.87%) 
Grade 3 Lung Fistula  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Lung-other  6/323 (1.86%)  6/345 (1.74%) 
Grade 4 Lung-other  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Pleural effusions  4/323 (1.24%)  3/345 (0.87%) 
Grade 3 Pneumonitis/infilitrates  35/323 (10.84%)  30/345 (8.70%) 
Grade 4 Pneumonitis/infiltrates  1/323 (0.31%)  4/345 (1.16%) 
Grade 3 Pneumothorax  5/323 (1.55%)  0/345 (0.00%) 
Grade 3 Pulmonary edema  1/323 (0.31%)  1/345 (0.29%) 
Grade 3 Voice charge /stridor/larynx  0/323 (0.00%)  1/345 (0.29%) 
Skin and subcutaneous tissue disorders     
Grade 3 Decubitus  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Erythema multifrme/blistering  1/323 (0.31%)  0/345 (0.00%) 
Grade 3 Erythema/rash/eruption/desquamation  6/323 (1.86%)  6/345 (1.74%) 
Grade 3 Pruritis  1/323 (0.31%)  2/345 (0.58%) 
Grade 3 Rash/desquamation  34/323 (10.53%)  36/345 (10.43%) 
Grade 4 Rash/desquamation  8/323 (2.48%)  5/345 (1.45%) 
Grade 3 Skin/other  4/323 (1.24%)  4/345 (1.16%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Thalidomide No Thalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   323/323 (100.00%)   345/345 (100.00%) 
Blood and lymphatic system disorders     
Grade 2 Anemia (HGB)  70/323 (21.67%)  76/345 (22.03%) 
Grade 3 Anemia (HGB)  161/323 (49.85%)  174/345 (50.43%) 
Grade 3 Neutropenia/ granulocytopenia  16/323 (4.95%)  20/345 (5.80%) 
Grade 3 PRBC transfusion  25/323 (7.74%)  0/345 (0.00%) 
Grade 3 Platelet Transfusion  16/323 (4.95%)  0/345 (0.00%) 
Grade 3 Thrombocytopenia (PLT)  99/323 (30.65%)  112/345 (32.46%) 
Grade 2 Hematuria  0/323 (0.00%)  16/345 (4.64%) 
Grade 1 Hemorrhage w/3-4 thrombocytopenia  40/323 (12.38%)  63/345 (18.26%) 
Cardiac disorders     
Grade 1 Arrythmia, NOS  70/323 (21.67%)  88/345 (25.51%) 
Grade 2 Arrythmia, NOS  21/323 (6.50%)  29/345 (8.41%) 
Grade 1 Edema  101/323 (31.27%)  83/345 (24.06%) 
Grade 2 Edema  33/323 (10.22%)  28/345 (8.12%) 
Grade 1 Sinus tachycardia  0/323 (0.00%)  16/345 (4.64%) 
Grade 2 Thrombosis/embolism  17/323 (5.26%)  21/345 (6.09%) 
Endocrine disorders     
Grade 1 Hypothyroidism  22/323 (6.81%)  21/345 (6.09%) 
Grade 2 Hypothyroidism  30/323 (9.29%)  0/345 (0.00%) 
Eye disorders     
Grade 2 Blurred vision  53/323 (16.41%)  47/345 (13.62%) 
Grade 1 Eye - other  24/323 (7.43%)  0/345 (0.00%) 
Grade 1 Vision, NOS  16/323 (4.95%)  0/345 (0.00%) 
Gastrointestinal disorders     
Grade 1 Anorexia  50/323 (15.48%)  62/345 (17.97%) 
Grade 2 Anorexia  42/323 (13.00%)  44/345 (12.75%) 
Grade 2 Colitis  0/323 (0.00%)  24/345 (6.96%) 
Grade 1 Constipation/bowel obstruction  55/323 (17.03%)  69/345 (20.00%) 
Grade 2 Constipation/bowel obstruction  143/323 (44.27%)  112/345 (32.46%) 
Grade 1 Diarrhea without colostomy  50/323 (15.48%)  51/345 (14.78%) 
Grade 2 Diarrhea without colostomy  119/323 (36.84%)  127/345 (36.81%) 
Grade 1 Dyspepsia/heartburn  27/323 (8.36%)  19/345 (5.51%) 
Grade 1 Esophagitis/dysphagia  70/323 (21.67%)  56/345 (16.23%) 
Grade 2 Esophagitis/dysphagia  54/323 (16.72%)  81/345 (23.48%) 
Grade 1 Mouth Dryness  52/323 (16.10%)  46/345 (13.33%) 
Grade 2 Mouth Dryness  73/323 (22.60%)  48/345 (13.91%) 
Grade 1 Nausea  46/323 (14.24%)  37/345 (10.72%) 
Grade 2 Nausea  83/323 (25.70%)  118/345 (34.20%) 
Grade 1 Stomatitis/pharyngitis  63/323 (19.50%)  66/345 (19.13%) 
Grade 2 Stomatitis/pharyngitis  73/323 (22.60%)  90/345 (26.09%) 
Grade 1 Taste Disturbance  0/323 (0.00%)  17/345 (4.93%) 
Grade 1 Vomiting  58/323 (17.96%)  65/345 (18.84%) 
Grade 2 Vomiting  105/323 (32.51%)  122/345 (35.36%) 
General disorders     
Grade 2 Fatigue/malaise/lethargy  79/323 (24.46%)  76/345 (22.03%) 
Grade 1 Fever without neutropenia  48/323 (14.86%)  45/345 (13.04%) 
Grade 2 Fever without neutropenia  32/323 (9.91%)  21/345 (6.09%) 
Grade 1 Fever, NOS  94/323 (29.10%)  112/345 (32.46%) 
Grade 2 Fever, NOS  72/323 (22.29%)  59/345 (17.10%) 
Grade 1 Flu-like symptoms-other  35/323 (10.84%)  27/345 (7.83%) 
Grade 1 Insomnia  21/323 (6.50%)  0/345 (0.00%) 
Grade 1 Rigors/chills  29/323 (8.98%)  14/345 (4.06%) 
Grade 1 sweating  37/323 (11.46%)  31/345 (8.99%) 
Grade 2 sweating  34/323 (10.53%)  36/345 (10.43%) 
Grade 1 Weight gain  36/323 (11.15%)  31/345 (8.99%) 
Grade 1 Weight loss  35/323 (10.84%)  37/345 (10.72%) 
Grade 1 Edema-limb  22/323 (6.81%)  0/345 (0.00%) 
Grade 1 Lymphedema  16/323 (4.95%)  0/345 (0.00%) 
Grade 1 Abdominal pain/cramping  20/323 (6.19%)  26/345 (7.54%) 
Grade 1 Arthralgia  60/323 (18.58%)  59/345 (17.10%) 
Grade 2 Arthralgia  23/323 (7.12%)  27/345 (7.83%) 
Grade 1 Bone pain  77/323 (23.84%)  70/345 (20.29%) 
Grade 2 Bone pain  55/323 (17.03%)  65/345 (18.84%) 
Grade 1 Pain/other  53/323 (16.41%)  77/345 (22.32%) 
Grade 2 Pain/other  74/323 (22.91%)  62/345 (17.97%) 
Grade 1 Upper back  40/323 (12.38%)  27/345 (7.83%) 
Grade 2 Upper back  35/323 (10.84%)  19/345 (5.51%) 
Grade 1 Stem cell infusion complication  0/323 (0.00%)  17/345 (4.93%) 
Hepatobiliary disorders     
Grade 1 Alkaline phosphatase increase  139/323 (43.03%)  149/345 (43.19%) 
Grade 2 Alkaline phosphatase increase  17/323 (5.26%)  21/345 (6.09%) 
Grade 1 Bilirubin increase  52/323 (16.10%)  62/345 (17.97%) 
Grade 2 Bilirubin increase  28/323 (8.67%)  24/345 (6.96%) 
Grade 1 Hypoalbuminemia  86/323 (26.63%)  93/345 (26.96%) 
Grade 2 Hypoalbuminemia  155/323 (47.99%)  179/345 (51.88%) 
Grade 1 SGOT (AST) increase  111/323 (34.37%)  124/345 (35.94%) 
Grade 2 SGOT (AST) increase  25/323 (7.74%)  30/345 (8.70%) 
Grade 1 SGPT (ALT) increase  131/323 (40.56%)  140/345 (40.58%) 
Grade 2 SGPT (ALT) increase  39/323 (12.07%)  57/345 (16.52%) 
Immune system disorders     
Grade 1 Allergic rhinitis  54/323 (16.72%)  42/345 (12.17%) 
Grade 1 Autoimmune reaction  25/323 (7.74%)  28/345 (8.12%) 
Infections and infestations     
Grade 2 Infection w/Grade 3 or 4 Neutrophils  21/323 (6.50%)  0/345 (0.00%) 
Grade 2 Infection w/o 3-4 Neutropenia  34/323 (10.53%)  33/345 (9.57%) 
Grade 2 Lung Infection ANC Bronchus  20/323 (6.19%)  15/345 (4.35%) 
Grade 2 Respiratory infection w/o neutrop  33/323 (10.22%)  46/345 (13.33%) 
Grade 1 Respiratory infection w/o neutrop  17/323 (5.26%)  0/345 (0.00%) 
Metabolism and nutrition disorders     
Grade 1 Bicarbonate decrease  194/323 (60.06%)  217/345 (62.90%) 
Grade 2 Bicarbonate decrease  28/323 (8.67%)  41/345 (11.88%) 
Grade 1 Hypercalcemia  34/323 (10.53%)  37/345 (10.72%) 
Grade 1 Hyperglycemia  48/323 (14.86%)  48/345 (13.91%) 
Grade 2 Hyperglycemia  152/323 (47.06%)  151/345 (43.77%) 
Grade 1 Hyperkalemia  78/323 (24.15%)  82/345 (23.77%) 
Grade 2 Hyperkalemia  29/323 (8.98%)  15/345 (4.35%) 
Grade 1 Hypermagnesemia  60/323 (18.58%)  52/345 (15.07%) 
Grade 1 Hypematremia  80/323 (24.77%)  74/345 (21.45%) 
Grade 1 Hypocalcemia  35/323 (10.84%)  41/345 (11.88%) 
Grade 2 Hypocalcemia  146/323 (45.20%)  160/345 (46.38%) 
Grade 1 Hypokalemia  175/323 (54.18%)  182/345 (52.75%) 
Grade 1 Hypomagnesemia  142/323 (43.96%)  158/345 (45.80%) 
Grade 2 Hypomagnesemia  119/323 (36.84%)  116/345 (33.62%) 
Grade 1 Hyponatremia  141/323 (43.65%)  179/345 (51.88%) 
Grade 2 Hypophosphatemia  75/323 (23.22%)  65/345 (18.84%) 
Grade 1 Joint, muscle, bone  44/323 (13.62%)  40/345 (11.59%) 
Musculoskeletal and connective tissue disorders     
Grade 2 Joint, muscle, bone  22/323 (6.81%)  0/345 (0.00%) 
Grade 1 Muscle weakness  34/323 (10.53%)  22/345 (6.38%) 
Grade 2 Muscle weakness  13/323 (4.02%)  20/345 (5.80%) 
Grade 1 Myalgia  40/323 (12.38%)  53/345 (15.36%) 
Grade 2 Myalgia  26/323 (8.05%)  14/345 (4.06%) 
Nervous system disorders     
Grade 1 Anxiety/agitation  79/323 (24.46%)  93/345 (26.96%) 
Grade 2 Anxiety/agitation  55/323 (17.03%)  44/345 (12.75%) 
Grade 1 Ataxia  45/323 (13.93%)  27/345 (7.83%) 
Grade 2 Ataxia  27/323 (8.36%)  0/345 (0.00%) 
Grade 1 Confusion  84/323 (26.01%)  92/345 (26.67%) 
Grade 2 Confusion  42/323 (13.00%)  35/345 (10.14%) 
Grade 1 Depression  85/323 (26.32%)  101/345 (29.28%) 
Grade 2 Depression  89/323 (27.55%)  94/345 (27.25%) 
Grade 1 Dizziness/light headedness  76/323 (23.53%)  76/345 (22.03%) 
Grade 2 Dizziness/light headedness  53/323 (16.41%)  41/345 (11.88%) 
Grade 1 Headache  48/323 (14.86%)  51/345 (14.78%) 
Grade 2 Headache  37/323 (11.46%)  29/345 (8.41%) 
Grade 1 Insomnia  46/323 (14.24%)  42/345 (12.17%) 
Grade 2 Insomnia  15/323 (4.64%)  0/345 (0.00%) 
Grade 1 Memory loss  20/323 (6.19%)  0/345 (0.00%) 
Grade 1 Mood/consciousness change  51/323 (15.79%)  36/345 (10.43%) 
Grade 2 Mood/consciousness change  35/323 (10.84%)  31/345 (8.99%) 
Grade 1 Sensory neuropathy  72/323 (22.29%)  134/345 (38.84%) 
Grade 2 Sensory/neuropathy  115/323 (35.60%)  62/345 (17.97%) 
Grade 1 Somnolence/consciousness loss  75/323 (23.22%)  78/345 (22.61%) 
Grade 2 Somnolence/consciousness loss  52/323 (16.10%)  34/345 (9.86%) 
Grade 1 Tremor  64/323 (19.81%)  51/345 (14.78%) 
Grade 2 Tremor  45/323 (13.93%)  32/345 (9.28%) 
Grade 1 Weakness (motor neuropathy)  45/323 (13.93%)  52/345 (15.07%) 
Grade 2 Weakness (motor neuropathy)  77/323 (23.84%)  54/345 (15.65%) 
Renal and urinary disorders     
Grade 1 Bladder Spasms  0/323 (0.00%)  21/345 (6.09%) 
Grade 1 Creatinine increase  77/323 (23.84%)  91/345 (26.38%) 
Grade 2 Creatinine increase  53/323 (16.41%)  62/345 (17.97%) 
Grade 1 Urinary frequency/urgency  32/323 (9.91%)  22/345 (6.38%) 
Respiratory, thoracic and mediastinal disorders     
Grade 1 Cough  113/323 (34.98%)  103/345 (29.86%) 
Grade 2 Cough  45/323 (13.93%)  31/345 (8.99%) 
Grade 2 Dyspnea  97/323 (30.03%)  92/345 (26.67%) 
Grade 2 Hypoxia  24/323 (7.43%)  24/345 (6.96%) 
Grade 2 Pneumonitis/infiltrates  20/323 (6.19%)  22/345 (6.38%) 
Skin and subcutaneous tissue disorders     
Grade 2 Alopecia  73/323 (22.60%)  79/345 (22.90%) 
Grade 1 Bruising  25/323 (7.74%)  27/345 (7.83%) 
Grade 1 Dry skin  60/323 (18.58%)  43/345 (12.46%) 
Grade 2 Dry skin  19/323 (5.88%)  0/345 (0.00%) 
Erythema/rash/eruption/desquamation  37/323 (11.46%)  37/345 (10.72%) 
Grade 2 Erythema/rash/eruption/desquamation  18/323 (5.57%)  12/345 (3.48%) 
Grade 1 Rash/desquamation  73/323 (22.60%)  86/345 (24.93%) 
Grade 2 Rash/desquamation  82/323 (25.39%)  93/345 (26.96%) 
Grade 4 Skin/other  21/323 (6.50%)  17/345 (4.93%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Bart Barlogie
Organization: UAMS Myeloma Institute
Phone: 501-526-6990 ext 2420
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00083551     History of Changes
Other Study ID Numbers: 5226
First Submitted: May 25, 2004
First Posted: May 27, 2004
Results First Submitted: August 24, 2015
Results First Posted: September 22, 2015
Last Update Posted: November 23, 2015