UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
Sponsor
University of Arkansas (Other)
Overall Status
Completed
CT.gov ID
NCT00083551
Collaborator
Celgene Corporation (Industry)
668
1
2
192
3.5
Study Details
Study Description
Brief Summary
This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Treatment will be given in 4 phases or steps: Induction, Transplant 1 and 2, Consolidation, and maintenance. Induction is designed to induce (or bring about) myeloma into remission. Each patient enrolled on this study will be randomly assigned to receive the above treatment alone or in combination with a drug called thalidomide. Some patients may be eligible to receive the transplant as an outpatient, based on general health and other factors.After recovery from the transplant phase of the study (approximately 6 weeks), patients originally assigned to thalidomide will resume taking it and will continue taking it throughout the rest of the study treatment. All patients will receive post-transplant consolidation treatment, which in earlier studies has been found to be helpful in maintaining patients response after transplant. Therefore, all patients will receive a combination of drugs called "D PACE" which consists of Dexamethasone, Cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide. If you are also taking thalidomide, you will continue taking it throughout, and the treatment is called "DT PACE" to include the thalidomide. No sooner than 4 weeks, and no later than 12 weeks after consolidation and if your myeloma remains in remission after consolidation therapy is complete, you will begin the last phase of the study, which is maintenance. Maintenance is designed to keep your myeloma in remission long-term.
Study Design
Study Type:
Interventional
Actual Enrollment
:
668 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
Study Start Date
:
Aug 1, 1998
Actual Primary Completion Date
:
Aug 1, 2014
Actual Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Thalidomide Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance |
Drug: Thalidomide
All patients will be randomly assigned to receive thalidomide 400 mg as an oral, once daily dose throughout induction and 100mg between transplants after platelets are greater than 50,000μl and 200 mg post transplant consolidation, and a reduced dose of 100 mg on alternating days during the first year of maintenance and 50 mg qod thereafter versus no thalidomide. Thalidomide will be held during conditioning, transplant procedure, and recovery following transplant. It may be resumed once plateletrecovery is complete after each transplant
Other Names:
Drug: Ara-C
Cytarabine (Ara-C) 400 mg/m2 in 250 ml D5W over one hour daily for four days (on days -5, -4, -3, -2).
Start infusion 30 minutes after completion of BCNU on day -5.
Other Names:
Drug: BCNU
Carmustine (BCNU) 300 mg/m2 in 1 liter of D5W in glass bottle (protect from light) to infuse over 2 hours on day -5. Check blood pressure every 15 minutes during infusion and 30 minutes after completion
Other Names:
Drug: Cisplatin
Cisplatin* 15 mg/m2/day Continuous infusion 1-4 (DCEP CYCLE 2) Cisplatin* 7.5 mg/m2 Continuous infusion 1-4 (DPACE cycle)
*Cisplatin doses will be modified for renal insufficiency as follows: Cisplatin dose Creatinine 15 mg/m2 (full dose) < 1.5 mg/dl 10 mg/m2 1.6 - 2.0 mg/dl 7.5 mg/m2 2.1 - 3.0 mg/dl 0 mg (hold Cisplatin) > 3.0 mg/dl
Other Names:
Drug: Cytoxan
Cycle 2 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cycle 3 - CAD and PBSC Collection #1 Cyclophosphamide 750 mg/m2/day Continuous infusion 1-4 Cycle 4 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cytoxan/VP-16 and PBSC Collection-Cyclophosphamide 2 grams/m2 (Total dose 4 gm/m2) IV by CI 1 and 2 Post-Transplant Consolidation-Cyclophosphamide 300 mg/m2 Continuous infusion 1-4
Other Names:
Drug: Dexamethasone
Induction cycle 1 VAD Dexamethasone 40 mg/day PO 1-4, 9-12, 17-20 Cycle 2 - DCEP Dexamethasone 40 mg/day PO 1-4 Cycle 3 - CAD and PBSC Collection #1 Dexamethasone 40 mg/day PO 1-4 Cycle 4 - DCEP and PBSC Collection #2 Dexamethasone 40 mg/day PO 1-4 Post-Transplant Consolidation Dexamethasone 40 mg PO 1-4 Dexamethasone Consolidation Patients that do not achieve adequate platelet recovery (defined as < 80,000/μl) will receive consolidation with Dexamethasone 40 mg x 4 days every 28 days for 1 year Maintenance year one Dexamethasone 40 mg PO q 3 months, day 1-4, 9-12, 17-20
Other Names:
Drug: Etoposide
Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
Other Names:
Drug: Filgrastim
G-CSF will be administered at a dose of 10mcg/kg or GM-CSF at a dose of 10 mcg/kg. G-CSF or GM-CSF will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
Other Names:
Drug: Recombinant GM-CSF
GM-CSF at a dose of 10 μg/kg SC, divided in 2 doses each day, will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
Drug: Interferon-alpha-2b
AGENT DOSE ROUTE DAYS Intron-A 3 million units/m2 SQ TIW Thalidomide (for those randomized at initial registration) 50 mg QOD PO Every other day (qod
Drug: Melphalan
Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
Other Names:
|
| Active Comparator: No Thalidomide During induction, consolidation, and maintenance steps patient receives no thalidamide |
Drug: Ara-C
Cytarabine (Ara-C) 400 mg/m2 in 250 ml D5W over one hour daily for four days (on days -5, -4, -3, -2).
Start infusion 30 minutes after completion of BCNU on day -5.
Other Names:
Drug: BCNU
Carmustine (BCNU) 300 mg/m2 in 1 liter of D5W in glass bottle (protect from light) to infuse over 2 hours on day -5. Check blood pressure every 15 minutes during infusion and 30 minutes after completion
Other Names:
Drug: Cisplatin
Cisplatin* 15 mg/m2/day Continuous infusion 1-4 (DCEP CYCLE 2) Cisplatin* 7.5 mg/m2 Continuous infusion 1-4 (DPACE cycle)
*Cisplatin doses will be modified for renal insufficiency as follows: Cisplatin dose Creatinine 15 mg/m2 (full dose) < 1.5 mg/dl 10 mg/m2 1.6 - 2.0 mg/dl 7.5 mg/m2 2.1 - 3.0 mg/dl 0 mg (hold Cisplatin) > 3.0 mg/dl
Other Names:
Drug: Cytoxan
Cycle 2 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cycle 3 - CAD and PBSC Collection #1 Cyclophosphamide 750 mg/m2/day Continuous infusion 1-4 Cycle 4 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cytoxan/VP-16 and PBSC Collection-Cyclophosphamide 2 grams/m2 (Total dose 4 gm/m2) IV by CI 1 and 2 Post-Transplant Consolidation-Cyclophosphamide 300 mg/m2 Continuous infusion 1-4
Other Names:
Drug: Dexamethasone
Induction cycle 1 VAD Dexamethasone 40 mg/day PO 1-4, 9-12, 17-20 Cycle 2 - DCEP Dexamethasone 40 mg/day PO 1-4 Cycle 3 - CAD and PBSC Collection #1 Dexamethasone 40 mg/day PO 1-4 Cycle 4 - DCEP and PBSC Collection #2 Dexamethasone 40 mg/day PO 1-4 Post-Transplant Consolidation Dexamethasone 40 mg PO 1-4 Dexamethasone Consolidation Patients that do not achieve adequate platelet recovery (defined as < 80,000/μl) will receive consolidation with Dexamethasone 40 mg x 4 days every 28 days for 1 year Maintenance year one Dexamethasone 40 mg PO q 3 months, day 1-4, 9-12, 17-20
Other Names:
Drug: Doxorubicin
Doxorubicin may be further diluted in 5% dextrose or sodium chloride injection and should be administered slowly into tubing of a freely flowing intravenous infusion with great care taken to avoid extravasation.
Other Names:
Drug: Etoposide
Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
Other Names:
Drug: Filgrastim
G-CSF will be administered at a dose of 10mcg/kg or GM-CSF at a dose of 10 mcg/kg. G-CSF or GM-CSF will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
Other Names:
Drug: Recombinant GM-CSF
GM-CSF at a dose of 10 μg/kg SC, divided in 2 doses each day, will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
Drug: Interferon-alpha-2b
AGENT DOSE ROUTE DAYS Intron-A 3 million units/m2 SQ TIW Thalidomide (for those randomized at initial registration) 50 mg QOD PO Every other day (qod
Drug: Melphalan
Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
Other Names:
Drug: Vincristine
Formulation: 1 mg/1 ml, 2 mg/2 ml, and 5 mg/ 5 ml vials. Vincristine should be administered intravenously through a freely-running IV. If it extravasates, it produces a severe local reaction with skin slough. FATAL IF GIVEN INTRATHECALLY, FOR INTRAVENOUS USE ONLY.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [6 Years]
Overall Survival at six years after initiating protocol therapy
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must have newly diagnosed active multiple myeloma requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
-
Protein criteria must be present in order to evaluate response.Non-secretory patients are eligible provided the patient has > or = 20% plasmacytosis or multiple (>3) focal plasmacytomas on MRI or diffuse hyperintense signal on STIR images in the absence of hematopoietic growth factors is seen.
-
All necessary baseline studies for determining stage, bloodwork, and bone marrow must be obtained within 35 days prior to registration.
-
Patients must have received no more than one cycle of prior chemotherapy including one month of Dexamethasone and Thalidomide for this disease. Patients may have received prior radiotherapy provided approval has been obtained by one of the study coordinators.
-
Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
-
Patients with renal failure, even if on dialysis, are eligible if it is felt to be due to myeloma and if the duration of renal failure does not exceed two months
-
Patients must be 75 years of age or less at the time of registration
-
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
-
If medically appropriate, patients with pathologic fractures, pneumonia at diagnosis or hyperviscosity with shortness of breath should have these conditions attended to prior to registration.
Exclusion Criteria:
-
Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection
-
Patients must not have uncontrolled diabetes
-
Patients with recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO or MUGA should be within the institutional normal range and must be performed within 42 days prior to registration.
-
Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease.
-
No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval and there must be no prior treatment with cytotoxic drugs that could potentially be assigned on this treatment protocol.
-
Pregnant or nursing women may not participate. Women of child-bearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences/MIRT | Little Rock | Arkansas | United States | 72205 |
Sponsors and Collaborators
- University of Arkansas
- Celgene Corporation
Investigators
- Principal Investigator: Bart Barlogie, M.D., Ph.D., UAMS
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083551
Other Study ID Numbers:
- 5226
First Posted:
May 27, 2004
Last Update Posted:
Nov 23, 2015
Last Verified:
Oct 1, 2015
Keywords provided by University of Arkansas
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Thalidomide | No Thalidomide |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Thalidomide | No Thalidomide | Total |
|---|---|---|---|
| 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 Participants | 323 | 345 | 668 |
| Age, Customized (participants) [Number] | |||
| >/= 60 to < 65 years |
130
40.2%
|
129
37.4%
|
259
38.8%
|
| >/= 65 years |
64
19.8%
|
72
20.9%
|
136
20.4%
|
| < 60 years |
129
39.9%
|
144
41.7%
|
273
40.9%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
137
42.4%
|
135
39.1%
|
272
40.7%
|
| Male |
186
57.6%
|
210
60.9%
|
396
59.3%
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | Overall Survival at six years after initiating protocol therapy |
| Time Frame | 6 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Thalidomide | No Thalidomide |
|---|---|---|
| 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. |
| Measure Participants | 323 | 345 |
| Number [percentage of participants] |
65
20.1%
|
58
16.8%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Thalidomide | No Thalidomide | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Thalidomide | No Thalidomide | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 323/323 (100%) | 345/345 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Grade 3 Clotting-other | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Prothrombin time increase | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Thrombotic microangiopathy | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 4 Anemia (HGB) | 27/323 (8.4%) | 34/345 (9.9%) | ||
| Grade 4 Neutropenia/granulocytopenia | 242/323 (74.9%) | 259/345 (75.1%) | ||
| Grade 4 Platelet transfusion | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 4 Thrombocytopenia (PLT) | 159/323 (49.2%) | 168/345 (48.7%) | ||
| Grade 4 Leukopenia (WBC) | 257/323 (79.6%) | 279/345 (80.9%) | ||
| Grade 3 Hematuria | 5/323 (1.5%) | 4/345 (1.2%) | ||
| Grade 4 Hematuria | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Hemorrhage w/3-4 thrombocytopenia | 38/323 (11.8%) | 37/345 (10.7%) | ||
| Grade 4 Hemorrhage w/3-4 thrombocytopenia | 6/323 (1.9%) | 10/345 (2.9%) | ||
| Grade 3 Hemorrhage w/o 3-4 thrombocytopenia | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Hemorrhage-other | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 4 Vaginal bleeding | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Petechiae/purpura | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Melena/GI bleeding | 6/323 (1.9%) | 9/345 (2.6%) | ||
| Grade 4 Melena/GI bleeding | 2/323 (0.6%) | 2/345 (0.6%) | ||
| Cardiac disorders | ||||
| Grade 3 Arrhythmia, NOS | 12/323 (3.7%) | 21/345 (6.1%) | ||
| Grade 4 Arrhythmia, NOS | 2/323 (0.6%) | 2/345 (0.6%) | ||
| Grade 3 Cardiac ischemia/infarction | 3/323 (0.9%) | 2/345 (0.6%) | ||
| Grade 4 Cardiac ischemia/infarction | 2/323 (0.6%) | 1/345 (0.3%) | ||
| Grade 3 Cardiovascular-other | 7/323 (2.2%) | 1/345 (0.3%) | ||
| Grade 4 Cardiovascular-other | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Cerebrovascular ischemia | 7/323 (2.2%) | 2/345 (0.6%) | ||
| Grade 4 Cerebrovascular ischemia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Conduction abnormality/block | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 4 Conduction abnormality/block | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Edema | 6/323 (1.9%) | 4/345 (1.2%) | ||
| Grade 3 Hypertension | 7/323 (2.2%) | 7/345 (2%) | ||
| Grade 3 Hypotension | 8/323 (2.5%) | 8/345 (2.3%) | ||
| Grade 4 Hypotension | 5/323 (1.5%) | 0/345 (0%) | ||
| Grade 3 LVEF decrease/CHF | 0/323 (0%) | 2/345 (0.6%) | ||
| Grade 3 Nodal/junctional dysrhythmia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Sinus bradycardia | 6/323 (1.9%) | 2/345 (0.6%) | ||
| Grade 4 Sinus bradycardia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Sinus tachycardia | 3/323 (0.9%) | 2/345 (0.6%) | ||
| Grade 3 Supraventricular arrhythmia | 7/323 (2.2%) | 7/345 (2%) | ||
| Grade 4 Supraventricular arrhythmia | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Surgery-injury of vein/artery | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Syncope | 31/323 (9.6%) | 12/345 (3.5%) | ||
| Grade 3 Thrombosis/embolism | 69/323 (21.4%) | 47/345 (13.6%) | ||
| Grade 4 Thrombosis/embolism | 11/323 (3.4%) | 3/345 (0.9%) | ||
| Grade 3 Valvular heart disease | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Vasovagal episode | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Ventricular arrhythmia | 2/323 (0.6%) | 3/345 (0.9%) | ||
| Grade 4 Ventricular arrhythmia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Supra Arrhyth: Atrial Fib. | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Cardiac/heart | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Chest/thorax | 0/323 (0%) | 1/345 (0.3%) | ||
| Ear and labyrinth disorders | ||||
| Grade 3 Hearing | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Inner ear - hearing loss | 8/323 (2.5%) | 0/345 (0%) | ||
| Grade 3 Middle ear - hearing loss/otitis | 2/323 (0.6%) | 1/345 (0.3%) | ||
| Grade 3 Earache | 2/323 (0.6%) | 0/345 (0%) | ||
| Endocrine disorders | ||||
| Grade 3 Diabetes | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Endocrine - other | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 SIADH | 0/323 (0%) | 1/345 (0.3%) | ||
| Eye disorders | ||||
| Grade 3 Blurred vision | 3/323 (0.9%) | 2/345 (0.6%) | ||
| Grade 3 Cataract | 10/323 (3.1%) | 4/345 (1.2%) | ||
| Grade 3 Double vision | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Eye - other | 2/323 (0.6%) | 1/345 (0.3%) | ||
| Grade 3 Keratitis | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Photophobia | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 4 Retinopathy | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Eye | 0/323 (0%) | 1/345 (0.3%) | ||
| Gastrointestinal disorders | ||||
| Grade 3 Anal incontinence | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Anorexia | 94/323 (29.1%) | 99/345 (28.7%) | ||
| Grade 4 Anorexia | 6/323 (1.9%) | 6/345 (1.7%) | ||
| Grade 3 Colitis | 8/323 (2.5%) | 5/345 (1.4%) | ||
| Grade 4 Colitis | 1/323 (0.3%) | 7/345 (2%) | ||
| Grade 3 Constipation/bowel obstruction | 31/323 (9.6%) | 17/345 (4.9%) | ||
| Grade 4 Constipation/bowel obstruction | 6/323 (1.9%) | 8/345 (2.3%) | ||
| Grade 3 Dehydration | 4/323 (1.2%) | 5/345 (1.4%) | ||
| Grade 3 Diarrhea with colostomy | 1/323 (0.3%) | 4/345 (1.2%) | ||
| Grade 3 Diarrhea without colostomy | 61/323 (18.9%) | 80/345 (23.2%) | ||
| Grade 4 Diarrhea without colostomy | 8/323 (2.5%) | 7/345 (2%) | ||
| Grade 3 Dyspepsia/heartburn | 3/323 (0.9%) | 2/345 (0.6%) | ||
| Grade 3 Esophagitis/dysphagia | 26/323 (8%) | 35/345 (10.1%) | ||
| Grade 4 Esophagitis/dysphagia | 10/323 (3.1%) | 7/345 (2%) | ||
| Grade 3 Dysphagia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 GI Mucositis, NOS | 20/323 (6.2%) | 10/345 (2.9%) | ||
| Grade 4 GI Mucositis, NOS | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 GI-other | 2/323 (0.6%) | 6/345 (1.7%) | ||
| Grade 4 GI-other | 2/323 (0.6%) | 1/345 (0.3%) | ||
| Grade 3 Ileus | 0/323 (0%) | 2/345 (0.6%) | ||
| Grade 3 Mouth Dryness | 7/323 (2.2%) | 5/345 (1.4%) | ||
| Grade 4 Mouth Dryness | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Nausea | 117/323 (36.2%) | 118/345 (34.2%) | ||
| Grade 4 Nausea | 3/323 (0.9%) | 4/345 (1.2%) | ||
| Grade 3 Pancreatitis | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Periodontal | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 RT-GI mucositis, NOS | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Stomatitis/pharyngitis | 60/323 (18.6%) | 41/345 (11.9%) | ||
| Grade 4 Stomatitis/pharyngitis | 7/323 (2.2%) | 12/345 (3.5%) | ||
| Grade 3 Vomiting | 37/323 (11.5%) | 42/345 (12.2%) | ||
| Grade 4 Vomiting | 6/323 (1.9%) | 8/345 (2.3%) | ||
| General disorders | ||||
| Grade 3 Fatigue/malaise/lethargy | 130/323 (40.2%) | 139/345 (40.3%) | ||
| Grade 4 Fatigue/malaise/lethargy | 40/323 (12.4%) | 52/345 (15.1%) | ||
| Grade 3 Fever without neutropenia | 2/323 (0.6%) | 8/345 (2.3%) | ||
| Grade 4 Fever without neutropenia | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Fever, NOS | 29/323 (9%) | 25/345 (7.2%) | ||
| Grade 4 Fever, NOS | 2/323 (0.6%) | 3/345 (0.9%) | ||
| Grade 3 Flu-like symptoms-other | 3/323 (0.9%) | 4/345 (1.2%) | ||
| Grade 3 Insomnia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Obesity | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Rigors/chills | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 4 Sweating | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Weight loss | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Abdominal pain/cramping | 10/323 (3.1%) | 8/345 (2.3%) | ||
| Grade 4 Abdominal pain/cramping | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Arthralgia | 6/323 (1.9%) | 8/345 (2.3%) | ||
| Grade 4 Arthralgia | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Bone pain | 24/323 (7.4%) | 18/345 (5.2%) | ||
| Grade 4 Bone pain | 4/323 (1.2%) | 4/345 (1.2%) | ||
| Grade 3 Chest pain/not cardio or pleural | 2/323 (0.6%) | 4/345 (1.2%) | ||
| Grade 3 Extremity/limb | 1/323 (0.3%) | 2/345 (0.6%) | ||
| Grade 3 Hepatic pain | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Hip-left | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Lower back | 1/323 (0.3%) | 3/345 (0.9%) | ||
| Grade 3 Neuropathic pain | 0/323 (0%) | 3/345 (0.9%) | ||
| Grade 3 Pain NOS | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Pain/other | 53/323 (16.4%) | 47/345 (13.6%) | ||
| Grade 4 Pain/other | 4/323 (1.2%) | 0/345 (0%) | ||
| Grade 3 Pelvic | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Pleuritic pain | 2/323 (0.6%) | 0/345 (0%) | ||
| Grade 3 Rectal/perirectal pain | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Rib | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Tumor pain | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Upper Back | 6/323 (1.9%) | 4/345 (1.2%) | ||
| Grade 3 Failure to engraft | 1/323 (0.3%) | 2/345 (0.6%) | ||
| Grade 3 Stem cell infusion complication | 0/323 (0%) | 2/345 (0.6%) | ||
| Grade 4 Stem cell infusion complication | 1/323 (0.3%) | 2/345 (0.6%) | ||
| Grade 3 Syndrome/other | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Thrombosis/embolism | 1/323 (0.3%) | 2/345 (0.6%) | ||
| Hepatobiliary disorders | ||||
| Grade 3 Alkaline phosphatase increase | 3/323 (0.9%) | 4/345 (1.2%) | ||
| Grade 3 Bilirubin increase | 8/323 (2.5%) | 9/345 (2.6%) | ||
| Grade 4 Bilirnbin increase | 4/323 (1.2%) | 2/345 (0.6%) | ||
| Grade 3 Hypoalbuminemia | 16/323 (5%) | 18/345 (5.2%) | ||
| Grade 3 Liver enlargement | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 SGOT (AST) increase | 9/323 (2.8%) | 7/345 (2%) | ||
| Grade 4 SGOT (AST) increase | 0/323 (0%) | 3/345 (0.9%) | ||
| Grade 3 SGPT (ALT) increase | 18/323 (5.6%) | 19/345 (5.5%) | ||
| Grade 4 SGPT (ALT) increase | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Immune system disorders | ||||
| Grade 3 Allergic/hypersensitivity | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Autoimmune reaction | 4/323 (1.2%) | 1/345 (0.3%) | ||
| Grade 4 Autoimmune reaction | 4/323 (1.2%) | 0/345 (0%) | ||
| Infections and infestations | ||||
| Grade 3 Catheter related infection | 11/323 (3.4%) | 18/345 (5.2%) | ||
| Grade 3 Ear infection ANC mid ear | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Febrile neutropenia | 62/323 (19.2%) | 80/345 (23.2%) | ||
| Grade 4 Febrile neutropenia | 0/323 (0%) | 2/345 (0.6%) | ||
| Grade 3 GI infection 3-4 ANC abdomen | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 GI infection 3-4 ANC appendix | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 GI Infection 3-4 ANC tooth | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 GI infection ANC abdomen | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 GU infection ABC UTI | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Infection w/grade 3 or 4 Neutrophils | 3/323 (0.9%) | 1/345 (0.3%) | ||
| Grade 3 Infection w/o 3-4 Neutropenia | 29/323 (9%) | 38/345 (11%) | ||
| Grade 4 Infection w/o 3-4 Neutropenia | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Infection w/3-4 Neutropenia | 28/323 (8.7%) | 27/345 (7.8%) | ||
| Grade 4 Infection w/3-4 Neutropenia | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Infection ANC | 27/323 (8.4%) | 25/345 (7.2%) | ||
| Grade 4 Infection ANC | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Lung infection 3-4 ANC | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Lung Infection ANC Bronchus | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Lung Infection ANC Lung | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Lung Infection ANC Pharynx | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Moderate | 1/323 (0.3%) | 2/345 (0.6%) | ||
| Grade 3 Respiratory infect w/neutrop | 4/323 (1.2%) | 2/345 (0.6%) | ||
| Grade 3 Muscle infection ANC Bone | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Respiratory infection w/o neutrop | 17/323 (5.3%) | 10/345 (2.9%) | ||
| Grade 4 Respiratory infection w/o neutrop | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Respiratory infection ANC | 18/323 (5.6%) | 11/345 (3.2%) | ||
| Grade 3 Skin infection 3-4 ANC lip/perior | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Surgery-wound infection | 2/323 (0.6%) | 0/345 (0%) | ||
| Grade 4 Surgery -wound infection | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Urinary tract infectiob w/neutrop | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Uninary tract infection w/o neutrop | 1/323 (0.3%) | 2/345 (0.6%) | ||
| Grade 4 Urinary tract infection w/o neutrop | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Urinary tract infection ANC | 2/323 (0.6%) | 3/345 (0.9%) | ||
| Metabolism and nutrition disorders | ||||
| Grade 3 Bicarbonate decrease | 8/323 (2.5%) | 5/345 (1.4%) | ||
| Grade 4 Bicarbonate decrease | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Hypercalcemia | 2/323 (0.6%) | 4/345 (1.2%) | ||
| Grade 4 Hypercalcemia | 6/323 (1.9%) | 2/345 (0.6%) | ||
| Grade 3 Hyperglycemia | 57/323 (17.6%) | 84/345 (24.3%) | ||
| Grade 4 Hyperglycemia | 10/323 (3.1%) | 10/345 (2.9%) | ||
| Grade 3 Hyperkalemia | 11/323 (3.4%) | 18/345 (5.2%) | ||
| Grade 4 Hyperkalemia | 5/323 (1.5%) | 3/345 (0.9%) | ||
| Grade 3 Hypermagnesemia | 14/323 (4.3%) | 21/345 (6.1%) | ||
| Grade 4 Hypermagnesemia | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Hypermatremia | 0/323 (0%) | 2/345 (0.6%) | ||
| Grade 4 Hyperuricemia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Hypocalcemia | 61/323 (18.9%) | 75/345 (21.7%) | ||
| Grade 4 Hypocalcemia | 20/323 (6.2%) | 17/345 (4.9%) | ||
| Grade 3 Hypokalemia | 72/323 (22.3%) | 89/345 (25.8%) | ||
| Grade 4 Hypokalemia | 6/323 (1.9%) | 3/345 (0.9%) | ||
| Grade 3 Hypomagnesemia | 0/323 (0%) | 10/345 (2.9%) | ||
| Grade 4 Hypomagnesemia | 2/323 (0.6%) | 0/345 (0%) | ||
| Grade 3 Hyponatremia | 101/323 (31.3%) | 95/345 (27.5%) | ||
| Grade 4 Hyponatremia | 14/323 (4.3%) | 8/345 (2.3%) | ||
| Grade 3 Hypophosphatemia | 183/323 (56.7%) | 214/345 (62%) | ||
| Grade 4 Hypophosphatemia | 0/323 (0%) | 3/345 (0.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Grade 3 Fracture | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 2 Gait/Walking | 3/323 (0.9%) | 0/345 (0%) | ||
| Grade 4 Gait/Walking | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Joint, muscle, bone | 19/323 (5.9%) | 6/345 (1.7%) | ||
| Grade 3 Muscle weakness | 6/323 (1.9%) | 5/345 (1.4%) | ||
| Grade 3 Osteonecrosis | 2/323 (0.6%) | 2/345 (0.6%) | ||
| Grade 3 Muscle | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Myalgia | 5/323 (1.5%) | 2/345 (0.6%) | ||
| Grade 3 Myalgia/arthralgia | 0/323 (0%) | 3/345 (0.9%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Grade 4 Second primary | 6/323 (1.9%) | 6/345 (1.7%) | ||
| Nervous system disorders | ||||
| Grade 3 Apnea | 2/323 (0.6%) | 0/345 (0%) | ||
| Grade 4 Apnea | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Anxiety/agitation | 8/323 (2.5%) | 16/345 (4.6%) | ||
| Grade 4 Anxiety/agitation | 3/323 (0.9%) | 5/345 (1.4%) | ||
| Grade 3 Ataxia | 10/323 (3.1%) | 6/345 (1.7%) | ||
| Grade 4 CNS ischemia | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Confusion | 25/323 (7.7%) | 23/345 (6.7%) | ||
| Grade 4 Confusion | 5/323 (1.5%) | 8/345 (2.3%) | ||
| Grade 3 Depression | 32/323 (9.9%) | 28/345 (8.1%) | ||
| Grade 4 Depression | 6/323 (1.9%) | 6/345 (1.7%) | ||
| Grade 3 Dizziness/light headedness | 35/323 (10.8%) | 15/345 (4.3%) | ||
| Grade 4 Dizziness/light headedness | 4/323 (1.2%) | 3/345 (0.9%) | ||
| Grade 3 Dizziness/vertigo | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Hallucinations | 4/323 (1.2%) | 2/345 (0.6%) | ||
| Grade 3 Headache | 11/323 (3.4%) | 19/345 (5.5%) | ||
| Grade 3 Insomnia | 4/323 (1.2%) | 4/345 (1.2%) | ||
| Grade 3 Involuntary movement/restlessnes | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Mood/consciousness change | 23/323 (7.1%) | 17/345 (4.9%) | ||
| Grade 4 Mood/consciousness change | 2/323 (0.6%) | 3/345 (0.9%) | ||
| Grade 3 Neuro-other | 3/323 (0.9%) | 3/345 (0.9%) | ||
| Grade 4 Neuro-other | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Seizures | 2/323 (0.6%) | 1/345 (0.3%) | ||
| Grade 4 Seizures | 0/323 (0%) | 3/345 (0.9%) | ||
| Grade 3 Sensory/neuropathy | 46/323 (14.2%) | 13/345 (3.8%) | ||
| Grade 4 Sensory/neuropathy | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Somnolence/consciousness loss | 40/323 (12.4%) | 32/345 (9.3%) | ||
| Grade 4 Somnolence/consciousness loss | 4/323 (1.2%) | 4/345 (1.2%) | ||
| Grade 3 Speech impairment | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Tremor | 32/323 (9.9%) | 15/345 (4.3%) | ||
| Grade4 Tremor | 2/323 (0.6%) | 1/345 (0.3%) | ||
| Grade 3 Weakness (motor neuropathy) | 55/323 (17%) | 36/345 (10.4%) | ||
| Grade 4 Weakness (motor neuropathy) | 3/323 (0.9%) | 5/345 (1.4%) | ||
| Renal and urinary disorders | ||||
| Grade 3 Bladder Spasms | 4/323 (1.2%) | 2/345 (0.6%) | ||
| Grade 4 Bladder Spasms | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Creatinine increase | 12/323 (3.7%) | 8/345 (2.3%) | ||
| Grade 4 Creatinine increase | 16/323 (5%) | 15/345 (4.3%) | ||
| Grade 3 GU-other | 2/323 (0.6%) | 1/345 (0.3%) | ||
| Grade 3 incontinence | 0/323 (0%) | 1/345 (0.3%) | ||
| Grade 3 Renal failure | 6/323 (1.9%) | 6/345 (1.7%) | ||
| Grade 4 Renal failure | 8/323 (2.5%) | 5/345 (1.4%) | ||
| Grade 3 Urinary frequency/urgency | 0/323 (0%) | 2/345 (0.6%) | ||
| Grade 3 Urinary retention | 1/323 (0.3%) | 0/345 (0%) | ||
| Reproductive system and breast disorders | ||||
| Grade 3 Erectile impotence | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Female sterility | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Menses changes | 1/323 (0.3%) | 0/345 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Grade 4 Acute respiratory distress syndrome | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Cough | 6/323 (1.9%) | 3/345 (0.9%) | ||
| Grade 3 Dyspnea | 18/323 (5.6%) | 12/345 (3.5%) | ||
| Grade 4 Dyspnea | 3/323 (0.9%) | 1/345 (0.3%) | ||
| Grade 3 Hiccoughs | 2/323 (0.6%) | 2/345 (0.6%) | ||
| Grade 3 Hypoxia | 33/323 (10.2%) | 37/345 (10.7%) | ||
| Grade 4 Hypoxia | 7/323 (2.2%) | 3/345 (0.9%) | ||
| Grade 3 Lung Fistula | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Lung-other | 6/323 (1.9%) | 6/345 (1.7%) | ||
| Grade 4 Lung-other | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Pleural effusions | 4/323 (1.2%) | 3/345 (0.9%) | ||
| Grade 3 Pneumonitis/infilitrates | 35/323 (10.8%) | 30/345 (8.7%) | ||
| Grade 4 Pneumonitis/infiltrates | 1/323 (0.3%) | 4/345 (1.2%) | ||
| Grade 3 Pneumothorax | 5/323 (1.5%) | 0/345 (0%) | ||
| Grade 3 Pulmonary edema | 1/323 (0.3%) | 1/345 (0.3%) | ||
| Grade 3 Voice charge /stridor/larynx | 0/323 (0%) | 1/345 (0.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Grade 3 Decubitus | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Erythema multifrme/blistering | 1/323 (0.3%) | 0/345 (0%) | ||
| Grade 3 Erythema/rash/eruption/desquamation | 6/323 (1.9%) | 6/345 (1.7%) | ||
| Grade 3 Pruritis | 1/323 (0.3%) | 2/345 (0.6%) | ||
| Grade 3 Rash/desquamation | 34/323 (10.5%) | 36/345 (10.4%) | ||
| Grade 4 Rash/desquamation | 8/323 (2.5%) | 5/345 (1.4%) | ||
| Grade 3 Skin/other | 4/323 (1.2%) | 4/345 (1.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Thalidomide | No Thalidomide | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 323/323 (100%) | 345/345 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Grade 2 Anemia (HGB) | 70/323 (21.7%) | 76/345 (22%) | ||
| Grade 3 Anemia (HGB) | 161/323 (49.8%) | 174/345 (50.4%) | ||
| Grade 3 Neutropenia/ granulocytopenia | 16/323 (5%) | 20/345 (5.8%) | ||
| Grade 3 PRBC transfusion | 25/323 (7.7%) | 0/345 (0%) | ||
| Grade 3 Platelet Transfusion | 16/323 (5%) | 0/345 (0%) | ||
| Grade 3 Thrombocytopenia (PLT) | 99/323 (30.7%) | 112/345 (32.5%) | ||
| Grade 2 Hematuria | 0/323 (0%) | 16/345 (4.6%) | ||
| Grade 1 Hemorrhage w/3-4 thrombocytopenia | 40/323 (12.4%) | 63/345 (18.3%) | ||
| Cardiac disorders | ||||
| Grade 1 Arrythmia, NOS | 70/323 (21.7%) | 88/345 (25.5%) | ||
| Grade 2 Arrythmia, NOS | 21/323 (6.5%) | 29/345 (8.4%) | ||
| Grade 1 Edema | 101/323 (31.3%) | 83/345 (24.1%) | ||
| Grade 2 Edema | 33/323 (10.2%) | 28/345 (8.1%) | ||
| Grade 1 Sinus tachycardia | 0/323 (0%) | 16/345 (4.6%) | ||
| Grade 2 Thrombosis/embolism | 17/323 (5.3%) | 21/345 (6.1%) | ||
| Endocrine disorders | ||||
| Grade 1 Hypothyroidism | 22/323 (6.8%) | 21/345 (6.1%) | ||
| Grade 2 Hypothyroidism | 30/323 (9.3%) | 0/345 (0%) | ||
| Eye disorders | ||||
| Grade 2 Blurred vision | 53/323 (16.4%) | 47/345 (13.6%) | ||
| Grade 1 Eye - other | 24/323 (7.4%) | 0/345 (0%) | ||
| Grade 1 Vision, NOS | 16/323 (5%) | 0/345 (0%) | ||
| Gastrointestinal disorders | ||||
| Grade 1 Anorexia | 50/323 (15.5%) | 62/345 (18%) | ||
| Grade 2 Anorexia | 42/323 (13%) | 44/345 (12.8%) | ||
| Grade 2 Colitis | 0/323 (0%) | 24/345 (7%) | ||
| Grade 1 Constipation/bowel obstruction | 55/323 (17%) | 69/345 (20%) | ||
| Grade 2 Constipation/bowel obstruction | 143/323 (44.3%) | 112/345 (32.5%) | ||
| Grade 1 Diarrhea without colostomy | 50/323 (15.5%) | 51/345 (14.8%) | ||
| Grade 2 Diarrhea without colostomy | 119/323 (36.8%) | 127/345 (36.8%) | ||
| Grade 1 Dyspepsia/heartburn | 27/323 (8.4%) | 19/345 (5.5%) | ||
| Grade 1 Esophagitis/dysphagia | 70/323 (21.7%) | 56/345 (16.2%) | ||
| Grade 2 Esophagitis/dysphagia | 54/323 (16.7%) | 81/345 (23.5%) | ||
| Grade 1 Mouth Dryness | 52/323 (16.1%) | 46/345 (13.3%) | ||
| Grade 2 Mouth Dryness | 73/323 (22.6%) | 48/345 (13.9%) | ||
| Grade 1 Nausea | 46/323 (14.2%) | 37/345 (10.7%) | ||
| Grade 2 Nausea | 83/323 (25.7%) | 118/345 (34.2%) | ||
| Grade 1 Stomatitis/pharyngitis | 63/323 (19.5%) | 66/345 (19.1%) | ||
| Grade 2 Stomatitis/pharyngitis | 73/323 (22.6%) | 90/345 (26.1%) | ||
| Grade 1 Taste Disturbance | 0/323 (0%) | 17/345 (4.9%) | ||
| Grade 1 Vomiting | 58/323 (18%) | 65/345 (18.8%) | ||
| Grade 2 Vomiting | 105/323 (32.5%) | 122/345 (35.4%) | ||
| General disorders | ||||
| Grade 2 Fatigue/malaise/lethargy | 79/323 (24.5%) | 76/345 (22%) | ||
| Grade 1 Fever without neutropenia | 48/323 (14.9%) | 45/345 (13%) | ||
| Grade 2 Fever without neutropenia | 32/323 (9.9%) | 21/345 (6.1%) | ||
| Grade 1 Fever, NOS | 94/323 (29.1%) | 112/345 (32.5%) | ||
| Grade 2 Fever, NOS | 72/323 (22.3%) | 59/345 (17.1%) | ||
| Grade 1 Flu-like symptoms-other | 35/323 (10.8%) | 27/345 (7.8%) | ||
| Grade 1 Insomnia | 21/323 (6.5%) | 0/345 (0%) | ||
| Grade 1 Rigors/chills | 29/323 (9%) | 14/345 (4.1%) | ||
| Grade 1 sweating | 37/323 (11.5%) | 31/345 (9%) | ||
| Grade 2 sweating | 34/323 (10.5%) | 36/345 (10.4%) | ||
| Grade 1 Weight gain | 36/323 (11.1%) | 31/345 (9%) | ||
| Grade 1 Weight loss | 35/323 (10.8%) | 37/345 (10.7%) | ||
| Grade 1 Edema-limb | 22/323 (6.8%) | 0/345 (0%) | ||
| Grade 1 Lymphedema | 16/323 (5%) | 0/345 (0%) | ||
| Grade 1 Abdominal pain/cramping | 20/323 (6.2%) | 26/345 (7.5%) | ||
| Grade 1 Arthralgia | 60/323 (18.6%) | 59/345 (17.1%) | ||
| Grade 2 Arthralgia | 23/323 (7.1%) | 27/345 (7.8%) | ||
| Grade 1 Bone pain | 77/323 (23.8%) | 70/345 (20.3%) | ||
| Grade 2 Bone pain | 55/323 (17%) | 65/345 (18.8%) | ||
| Grade 1 Pain/other | 53/323 (16.4%) | 77/345 (22.3%) | ||
| Grade 2 Pain/other | 74/323 (22.9%) | 62/345 (18%) | ||
| Grade 1 Upper back | 40/323 (12.4%) | 27/345 (7.8%) | ||
| Grade 2 Upper back | 35/323 (10.8%) | 19/345 (5.5%) | ||
| Grade 1 Stem cell infusion complication | 0/323 (0%) | 17/345 (4.9%) | ||
| Hepatobiliary disorders | ||||
| Grade 1 Alkaline phosphatase increase | 139/323 (43%) | 149/345 (43.2%) | ||
| Grade 2 Alkaline phosphatase increase | 17/323 (5.3%) | 21/345 (6.1%) | ||
| Grade 1 Bilirubin increase | 52/323 (16.1%) | 62/345 (18%) | ||
| Grade 2 Bilirubin increase | 28/323 (8.7%) | 24/345 (7%) | ||
| Grade 1 Hypoalbuminemia | 86/323 (26.6%) | 93/345 (27%) | ||
| Grade 2 Hypoalbuminemia | 155/323 (48%) | 179/345 (51.9%) | ||
| Grade 1 SGOT (AST) increase | 111/323 (34.4%) | 124/345 (35.9%) | ||
| Grade 2 SGOT (AST) increase | 25/323 (7.7%) | 30/345 (8.7%) | ||
| Grade 1 SGPT (ALT) increase | 131/323 (40.6%) | 140/345 (40.6%) | ||
| Grade 2 SGPT (ALT) increase | 39/323 (12.1%) | 57/345 (16.5%) | ||
| Immune system disorders | ||||
| Grade 1 Allergic rhinitis | 54/323 (16.7%) | 42/345 (12.2%) | ||
| Grade 1 Autoimmune reaction | 25/323 (7.7%) | 28/345 (8.1%) | ||
| Infections and infestations | ||||
| Grade 2 Infection w/Grade 3 or 4 Neutrophils | 21/323 (6.5%) | 0/345 (0%) | ||
| Grade 2 Infection w/o 3-4 Neutropenia | 34/323 (10.5%) | 33/345 (9.6%) | ||
| Grade 2 Lung Infection ANC Bronchus | 20/323 (6.2%) | 15/345 (4.3%) | ||
| Grade 2 Respiratory infection w/o neutrop | 33/323 (10.2%) | 46/345 (13.3%) | ||
| Grade 1 Respiratory infection w/o neutrop | 17/323 (5.3%) | 0/345 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Grade 1 Bicarbonate decrease | 194/323 (60.1%) | 217/345 (62.9%) | ||
| Grade 2 Bicarbonate decrease | 28/323 (8.7%) | 41/345 (11.9%) | ||
| Grade 1 Hypercalcemia | 34/323 (10.5%) | 37/345 (10.7%) | ||
| Grade 1 Hyperglycemia | 48/323 (14.9%) | 48/345 (13.9%) | ||
| Grade 2 Hyperglycemia | 152/323 (47.1%) | 151/345 (43.8%) | ||
| Grade 1 Hyperkalemia | 78/323 (24.1%) | 82/345 (23.8%) | ||
| Grade 2 Hyperkalemia | 29/323 (9%) | 15/345 (4.3%) | ||
| Grade 1 Hypermagnesemia | 60/323 (18.6%) | 52/345 (15.1%) | ||
| Grade 1 Hypematremia | 80/323 (24.8%) | 74/345 (21.4%) | ||
| Grade 1 Hypocalcemia | 35/323 (10.8%) | 41/345 (11.9%) | ||
| Grade 2 Hypocalcemia | 146/323 (45.2%) | 160/345 (46.4%) | ||
| Grade 1 Hypokalemia | 175/323 (54.2%) | 182/345 (52.8%) | ||
| Grade 1 Hypomagnesemia | 142/323 (44%) | 158/345 (45.8%) | ||
| Grade 2 Hypomagnesemia | 119/323 (36.8%) | 116/345 (33.6%) | ||
| Grade 1 Hyponatremia | 141/323 (43.7%) | 179/345 (51.9%) | ||
| Grade 2 Hypophosphatemia | 75/323 (23.2%) | 65/345 (18.8%) | ||
| Grade 1 Joint, muscle, bone | 44/323 (13.6%) | 40/345 (11.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Grade 2 Joint, muscle, bone | 22/323 (6.8%) | 0/345 (0%) | ||
| Grade 1 Muscle weakness | 34/323 (10.5%) | 22/345 (6.4%) | ||
| Grade 2 Muscle weakness | 13/323 (4%) | 20/345 (5.8%) | ||
| Grade 1 Myalgia | 40/323 (12.4%) | 53/345 (15.4%) | ||
| Grade 2 Myalgia | 26/323 (8%) | 14/345 (4.1%) | ||
| Nervous system disorders | ||||
| Grade 1 Anxiety/agitation | 79/323 (24.5%) | 93/345 (27%) | ||
| Grade 2 Anxiety/agitation | 55/323 (17%) | 44/345 (12.8%) | ||
| Grade 1 Ataxia | 45/323 (13.9%) | 27/345 (7.8%) | ||
| Grade 2 Ataxia | 27/323 (8.4%) | 0/345 (0%) | ||
| Grade 1 Confusion | 84/323 (26%) | 92/345 (26.7%) | ||
| Grade 2 Confusion | 42/323 (13%) | 35/345 (10.1%) | ||
| Grade 1 Depression | 85/323 (26.3%) | 101/345 (29.3%) | ||
| Grade 2 Depression | 89/323 (27.6%) | 94/345 (27.2%) | ||
| Grade 1 Dizziness/light headedness | 76/323 (23.5%) | 76/345 (22%) | ||
| Grade 2 Dizziness/light headedness | 53/323 (16.4%) | 41/345 (11.9%) | ||
| Grade 1 Headache | 48/323 (14.9%) | 51/345 (14.8%) | ||
| Grade 2 Headache | 37/323 (11.5%) | 29/345 (8.4%) | ||
| Grade 1 Insomnia | 46/323 (14.2%) | 42/345 (12.2%) | ||
| Grade 2 Insomnia | 15/323 (4.6%) | 0/345 (0%) | ||
| Grade 1 Memory loss | 20/323 (6.2%) | 0/345 (0%) | ||
| Grade 1 Mood/consciousness change | 51/323 (15.8%) | 36/345 (10.4%) | ||
| Grade 2 Mood/consciousness change | 35/323 (10.8%) | 31/345 (9%) | ||
| Grade 1 Sensory neuropathy | 72/323 (22.3%) | 134/345 (38.8%) | ||
| Grade 2 Sensory/neuropathy | 115/323 (35.6%) | 62/345 (18%) | ||
| Grade 1 Somnolence/consciousness loss | 75/323 (23.2%) | 78/345 (22.6%) | ||
| Grade 2 Somnolence/consciousness loss | 52/323 (16.1%) | 34/345 (9.9%) | ||
| Grade 1 Tremor | 64/323 (19.8%) | 51/345 (14.8%) | ||
| Grade 2 Tremor | 45/323 (13.9%) | 32/345 (9.3%) | ||
| Grade 1 Weakness (motor neuropathy) | 45/323 (13.9%) | 52/345 (15.1%) | ||
| Grade 2 Weakness (motor neuropathy) | 77/323 (23.8%) | 54/345 (15.7%) | ||
| Renal and urinary disorders | ||||
| Grade 1 Bladder Spasms | 0/323 (0%) | 21/345 (6.1%) | ||
| Grade 1 Creatinine increase | 77/323 (23.8%) | 91/345 (26.4%) | ||
| Grade 2 Creatinine increase | 53/323 (16.4%) | 62/345 (18%) | ||
| Grade 1 Urinary frequency/urgency | 32/323 (9.9%) | 22/345 (6.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Grade 1 Cough | 113/323 (35%) | 103/345 (29.9%) | ||
| Grade 2 Cough | 45/323 (13.9%) | 31/345 (9%) | ||
| Grade 2 Dyspnea | 97/323 (30%) | 92/345 (26.7%) | ||
| Grade 2 Hypoxia | 24/323 (7.4%) | 24/345 (7%) | ||
| Grade 2 Pneumonitis/infiltrates | 20/323 (6.2%) | 22/345 (6.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Grade 2 Alopecia | 73/323 (22.6%) | 79/345 (22.9%) | ||
| Grade 1 Bruising | 25/323 (7.7%) | 27/345 (7.8%) | ||
| Grade 1 Dry skin | 60/323 (18.6%) | 43/345 (12.5%) | ||
| Grade 2 Dry skin | 19/323 (5.9%) | 0/345 (0%) | ||
| Erythema/rash/eruption/desquamation | 37/323 (11.5%) | 37/345 (10.7%) | ||
| Grade 2 Erythema/rash/eruption/desquamation | 18/323 (5.6%) | 12/345 (3.5%) | ||
| Grade 1 Rash/desquamation | 73/323 (22.6%) | 86/345 (24.9%) | ||
| Grade 2 Rash/desquamation | 82/323 (25.4%) | 93/345 (27%) | ||
| Grade 4 Skin/other | 21/323 (6.5%) | 17/345 (4.9%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Bart Barlogie |
|---|---|
| Organization | UAMS Myeloma Institute |
| Phone | 501-526-6990 ext 2420 |
| barlogiebart@uams.edu |
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083551
Other Study ID Numbers:
- 5226
First Posted:
May 27, 2004
Last Update Posted:
Nov 23, 2015
Last Verified:
Oct 1, 2015