Trial Outcomes & Findings for UARK 2003-33, Total Therapy III (NCT NCT00081939)
NCT ID: NCT00081939
Last Updated: 2017-10-17
Results Overview
In patients with no confirmed Partial Response, Near Complete Response, or Complete Response, progression was defined as a \>25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
303 participants
Primary outcome timeframe
3 years
Results posted on
2017-10-17
Participant Flow
Participant milestones
| Measure |
Study Treatment
Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
|
|---|---|
|
Overall Study
STARTED
|
303
|
|
Overall Study
COMPLETED
|
303
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UARK 2003-33, Total Therapy III
Baseline characteristics by cohort
| Measure |
Study Treatment
n=303 Participants
Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
219 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsIn patients with no confirmed Partial Response, Near Complete Response, or Complete Response, progression was defined as a \>25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.
Outcome measures
| Measure |
Study Treatment
n=303 Participants
Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
|
|---|---|
|
Percentage of Participants With Progression-Free Survival (PFS) at 3 Years From Initiation of Study Treatment
|
77 percentage of participants
|
Adverse Events
Study Treatment
Serious events: 303 serious events
Other events: 303 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Treatment
n=303 participants at risk
Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
|
|---|---|
|
Immune system disorders
Grade 3 Allergic reaction/hypersensitivity
|
2.3%
7/303
|
|
Immune system disorders
Grade 4 Allergic reaction/Hypersensitivity
|
0.66%
2/303
|
|
Immune system disorders
Grade 4 Allergy-other
|
0.33%
1/303
|
|
Immune system disorders
Grade 3 Autoimmune reaction
|
0.33%
1/303
|
|
Ear and labyrinth disorders
Grade 3 Hearing
|
1.3%
4/303
|
|
Blood and lymphatic system disorders
Grade 3 Anemia (HGB)
|
45.9%
139/303
|
|
Blood and lymphatic system disorders
Grade 4 Anemia (HGB)
|
15.8%
48/303
|
|
Blood and lymphatic system disorders
Grade 3 CD4 count
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Lymphopenia
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Neutropenia/granulocytopenia
|
1.3%
4/303
|
|
Blood and lymphatic system disorders
Grade 4 Neutropenia/granulocytopenia
|
38.0%
115/303
|
|
Blood and lymphatic system disorders
Grade 3 Thrombocytopenia (PLT)
|
2.0%
6/303
|
|
Blood and lymphatic system disorders
Grade 4 Thrombocytopenia (PLT)
|
97.7%
296/303
|
|
Blood and lymphatic system disorders
Grade 4 Leukopenia
|
100.0%
303/303
|
|
Cardiac disorders
Grade 3 AV Block-Type 2
|
0.33%
1/303
|
|
Cardiac disorders
Grade 5 Asystole
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Febrile Neutropenia
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Hypertension
|
1.3%
4/303
|
|
Cardiac disorders
Grade 3 Hypotension
|
1.3%
4/303
|
|
Cardiac disorders
Grade 4 Hypotension
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Left vent. systolic dysfunction
|
0.33%
1/303
|
|
Cardiac disorders
Grade 4 Left vent systolic dysfunction
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Supra Arrhythmia: atrial fib.
|
2.3%
7/303
|
|
Cardiac disorders
Grade 4 Supra Arrhyth: Atrial Fib
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Supra Arrhyth: Atrial Flut
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Supra Arrhyth: Sinus Brady
|
0.33%
1/303
|
|
Cardiac disorders
Grade 4 Valvular heart disease
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Vasovagal episode
|
0.66%
2/303
|
|
Cardiac disorders
Grade 5 Vent arrhyth: Bigeminy
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Ventricular Arrythmia
|
2.3%
7/303
|
|
Cardiac disorders
Grade 4 Ventricular Arrythmia
|
0.66%
2/303
|
|
Cardiac disorders
Grade 5 Ventricular Arrythmia
|
0.33%
1/303
|
|
Cardiac disorders
Grade 3 Cardiac General
|
0.66%
2/303
|
|
Cardiac disorders
Grade 3 Cardiac ischemia/infarction
|
0.99%
3/303
|
|
Cardiac disorders
Grade 4 Cardiac ischemia/infarction
|
0.99%
3/303
|
|
Cardiac disorders
Grade 4 Cardiopulmonary arrest
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Coagulation-other
|
0.33%
1/303
|
|
General disorders
Grade 3 Constitutional symptoms-other
|
2.0%
6/303
|
|
General disorders
Grade 4 Constitutional symptoms-other
|
0.33%
1/303
|
|
General disorders
Grade 5 Constitutional symptoms-other
|
0.33%
1/303
|
|
General disorders
Grade 3 Fatigue-lethargy, malaise, asthenia
|
51.8%
157/303
|
|
General disorders
Grade 4 Fatigue-lethargy, malaise, asthenia
|
11.9%
36/303
|
|
General disorders
Grade 3 Fatigue-malaise, lethargy
|
0.33%
1/303
|
|
General disorders
Grade 3 Fever (in absence of neutropenia)
|
1.3%
4/303
|
|
General disorders
Grade 5 Fever (absence of neutropenia)
|
0.33%
1/303
|
|
General disorders
Grade 3 Insomnia
|
0.99%
3/303
|
|
General disorders
Grade 4 Insomnia
|
0.33%
1/303
|
|
General disorders
Grade 3 Obesity
|
0.33%
1/303
|
|
General disorders
Grade 3 Sweating
|
0.33%
1/303
|
|
General disorders
Grade 3 Weight loss
|
0.33%
1/303
|
|
General disorders
Grade 3 Weight gain
|
0.33%
1/303
|
|
Skin and subcutaneous tissue disorders
Grade 3 Dermatology-other
|
0.33%
1/303
|
|
Skin and subcutaneous tissue disorders
Grade 3 Dry skin
|
0.33%
1/303
|
|
Skin and subcutaneous tissue disorders
Grade 3 Pruritus
|
0.66%
2/303
|
|
Skin and subcutaneous tissue disorders
Grade 3 Skin rash/desquamation
|
6.9%
21/303
|
|
Skin and subcutaneous tissue disorders
Grade 4 Skin rash/desquamation
|
0.99%
3/303
|
|
Skin and subcutaneous tissue disorders
Grade 3 Ulceration
|
0.66%
2/303
|
|
Endocrine disorders
Grade 3 Diabetes
|
4.0%
12/303
|
|
Endocrine disorders
Grade 3 Hot flashes
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 3 Anorexia
|
35.3%
107/303
|
|
Gastrointestinal disorders
Grade 4 Anorexia
|
1.7%
5/303
|
|
Gastrointestinal disorders
Grade 3 Colitis
|
8.6%
26/303
|
|
Gastrointestinal disorders
Grade 4 Colitis
|
0.99%
3/303
|
|
Gastrointestinal disorders
Grade 5 Colitis
|
0.66%
2/303
|
|
Gastrointestinal disorders
Grade 3 Constipation
|
3.3%
10/303
|
|
Gastrointestinal disorders
Grade 4 Constipation
|
0.66%
2/303
|
|
Gastrointestinal disorders
Grade 3 Dehydration
|
4.0%
12/303
|
|
Gastrointestinal disorders
Grade 3 Diarrhea
|
25.1%
76/303
|
|
Gastrointestinal disorders
Grade 4 Diarrhea
|
0.99%
3/303
|
|
Gastrointestinal disorders
Grade 3 Distension
|
0.66%
2/303
|
|
Gastrointestinal disorders
Grade 3 Dry mouth
|
0.66%
2/303
|
|
Gastrointestinal disorders
Grade 3 Dysphagia
|
8.3%
25/303
|
|
Gastrointestinal disorders
Grade 3 Esophagitis
|
7.3%
22/303
|
|
Gastrointestinal disorders
Grade 3 GI Necrosis gallblader
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 3 GI Obstruction cecum
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 4 GI Obstruction cecum
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 3 GI Perforation appendix
|
0.66%
2/303
|
|
Gastrointestinal disorders
Grade 3 GI-other
|
2.0%
6/303
|
|
Gastrointestinal disorders
Grade 3 Gastritis
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 3 Heartburn
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 3 Hemorrhoids
|
0.66%
2/303
|
|
Gastrointestinal disorders
Grade 3 Mucositis/Stomatitis
|
9.2%
28/303
|
|
Gastrointestinal disorders
Grade 4 Mucositis/Stomatitis
|
0.99%
3/303
|
|
Gastrointestinal disorders
Grade 3 Nausea
|
18.5%
56/303
|
|
Gastrointestinal disorders
Grade 4 Nausea
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 3 Taste alteration
|
0.33%
1/303
|
|
Gastrointestinal disorders
Grade 3 Vomiting
|
5.9%
18/303
|
|
Gastrointestinal disorders
Grade 4 Vomiting
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Hematoma
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Hemorrhage, lower GI
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 4 Hemorrhage, lower GI
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Hemorrhage, upper GI
|
0.99%
3/303
|
|
Blood and lymphatic system disorders
Grade 3 Hemorrhage-other
|
0.33%
1/303
|
|
Hepatobiliary disorders
Grade 3 Alkaline phosphatase increase
|
2.6%
8/303
|
|
Hepatobiliary disorders
Grade 3 Bilirubin increase
|
4.0%
12/303
|
|
Hepatobiliary disorders
Grade 4 Bilirubin increase
|
0.33%
1/303
|
|
Hepatobiliary disorders
Grade 3 Cholecystitis
|
0.33%
1/303
|
|
Hepatobiliary disorders
Grade 3 Hypoalbuminemia
|
17.5%
53/303
|
|
Hepatobiliary disorders
Grade 3 SGOT (AST) increase
|
4.6%
14/303
|
|
Hepatobiliary disorders
Grade 4 SGOT (AST) increase
|
0.99%
3/303
|
|
Hepatobiliary disorders
Grade 3 SGPT (ALT) increase
|
5.9%
18/303
|
|
Hepatobiliary disorders
Grade 4 SGPT (ALT) increase
|
0.99%
3/303
|
|
Infections and infestations
Grade 3 Colitis infectious
|
4.0%
12/303
|
|
Infections and infestations
Grade 4 Colitis infectious
|
0.66%
2/303
|
|
Infections and infestations
Grade 3 Febrile neutropenia
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Febrile neutropenia (ANC, fever)
|
34.0%
103/303
|
|
Infections and infestations
Grade 4 Febrile neutropenia (ANC, fever)
|
0.99%
3/303
|
|
Infections and infestations
Grade 3 GI Infection 3-4 ANC abdomen
|
1.3%
4/303
|
|
Infections and infestations
Grade 3 GI Infection 3-4 ANC Appendix
|
0.66%
2/303
|
|
Infections and infestations
Grade 3 GI Infection 3-4 ANC Colon
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 GI Infection Unk ANC Abdomen
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 GU Infection 3-4 ANC Bladder
|
0.99%
3/303
|
|
Infections and infestations
Grade 3 GU Infection Unk ANC UTI
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection 3-4 ANC Blood
|
3.6%
11/303
|
|
Infections and infestations
Grade 4 Infection 3-4 ANC Blood
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection 3-4 ANC Cath-related
|
0.99%
3/303
|
|
Infections and infestations
Grade 3 Infection 3-4 ANC Wound
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection Unk ANC Cath-related
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection Unk ANC for body
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection (documented clinically or microbiologically)
|
9.6%
29/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC Musculoskeletal
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC skin
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC GI mild
|
0.66%
2/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC Dermatology
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC Gastrointestinal
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC General
|
2.3%
7/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC Neurology
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection w/normal ANC Renal/Genitourinary
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection w/unknown ANC
|
0.33%
1/303
|
|
Infections and infestations
Grade 5 Infection w/unknown ANC
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Infection Clinical Doc. w/high ANC/Pulmonary
|
0.66%
2/303
|
|
Infections and infestations
Grade 3 Infection Normal ANC Lung (Bronchus)
|
9.2%
28/303
|
|
Infections and infestations
Grade 3 Infection Normal Lung (Pneumonia)
|
1.7%
5/303
|
|
Infections and infestations
Grade 3 Infection other
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Lung infection-Bronchus
|
1.3%
4/303
|
|
Infections and infestations
Grade 3 Lung Infection-lung
|
5.0%
15/303
|
|
Infections and infestations
Grade 5 Lung infection-lung
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Lung infection-sinus
|
1.7%
5/303
|
|
Infections and infestations
Grade 3 Lung infection-upper airway
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Lung infection Unk ANC-bronchus
|
2.3%
7/303
|
|
Infections and infestations
Grade 3 Lung infection Unk ANC-lung
|
2.0%
6/303
|
|
Infections and infestations
Grade 3 Lung infection normal ANC-nose
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Opportunistic infection associated w/lymphopenia
|
36.3%
110/303
|
|
Infections and infestations
Grade 4 Opportunistic infection associated w/lymphopenia
|
0.33%
1/303
|
|
Infections and infestations
Grade 5 Opportunistic infection associated w/lymphopenia
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Viral hepatitis
|
0.33%
1/303
|
|
Infections and infestations
Grade 5 Lung infection Unk ANC-bronchus
|
0.33%
1/303
|
|
Infections and infestations
Grade 3 Skin infection Unk ANC-skin
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Edema-head and neck
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Edema-limb
|
3.0%
9/303
|
|
Blood and lymphatic system disorders
Grade 3 Edema-trunk/genital
|
0.33%
1/303
|
|
Blood and lymphatic system disorders
Grade 3 Lymphatics-other
|
0.99%
3/303
|
|
Metabolism and nutrition disorders
Grade 3 Acidosis
|
0.99%
3/303
|
|
Metabolism and nutrition disorders
Grade 3 Bicarbonate decrease
|
2.6%
8/303
|
|
Metabolism and nutrition disorders
Grade 4 Bicarbonate decrease
|
2.6%
8/303
|
|
Metabolism and nutrition disorders
Grade 3 GGT(Gamma-glutamyl transferase)
|
0.33%
1/303
|
|
Metabolism and nutrition disorders
Grade 3 Hypercalcemia
|
0.33%
1/303
|
|
Metabolism and nutrition disorders
Grade 4 Hypercalcemia
|
2.3%
7/303
|
|
Metabolism and nutrition disorders
Grade 3 Hyperglycemia
|
36.0%
109/303
|
|
Metabolism and nutrition disorders
Grade 4 Hyperglycemia
|
4.6%
14/303
|
|
Metabolism and nutrition disorders
Grade 3 Hyperkalemia
|
5.6%
17/303
|
|
Metabolism and nutrition disorders
Grade 4 Hyperkalemia
|
2.0%
6/303
|
|
Metabolism and nutrition disorders
Grade 3 Hypermagnesemia
|
2.3%
7/303
|
|
Metabolism and nutrition disorders
Grade 4 Hypermagnesemia
|
0.33%
1/303
|
|
Metabolism and nutrition disorders
Grade 3 Hypernatremia
|
0.66%
2/303
|
|
Metabolism and nutrition disorders
Grade 3 Hypocalcemia
|
32.3%
98/303
|
|
Metabolism and nutrition disorders
Grade 4 Hypocalcemia
|
6.6%
20/303
|
|
Metabolism and nutrition disorders
Grade 3 Hypokalemia
|
39.6%
120/303
|
|
Metabolism and nutrition disorders
Grade 4 Hypokalemia
|
5.0%
15/303
|
|
Metabolism and nutrition disorders
Grade 3 Hypomagnesemia
|
1.7%
5/303
|
|
Metabolism and nutrition disorders
Grade 4 Hypomagnesemia
|
0.66%
2/303
|
|
Metabolism and nutrition disorders
Grade 3 Hyponatremia
|
61.4%
186/303
|
|
Metabolism and nutrition disorders
Grade 4 Hyponatremia
|
3.3%
10/303
|
|
Metabolism and nutrition disorders
Grade 3 Hypophosphatemia
|
77.9%
236/303
|
|
Metabolism and nutrition disorders
Grade 4 Hypophosphatemia
|
3.6%
11/303
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Device/prosthesis
|
0.33%
1/303
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Fracture
|
2.6%
8/303
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Gait/walking
|
2.6%
8/303
|
|
Musculoskeletal and connective tissue disorders
Grade 4 Gait/walking
|
0.33%
1/303
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Muscle weakness-lower extrem.
|
0.99%
3/303
|
|
Musculoskeletal and connective tissue disorders
Grade 4 Muscle weakness-whole body
|
0.33%
1/303
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Muscle weakness-whole body
|
4.0%
12/303
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Musculoskeletal-other
|
1.7%
5/303
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Soft tissue-abdomen
|
0.33%
1/303
|
|
Nervous system disorders
Grade 3 Ataxia
|
1.7%
5/303
|
|
Nervous system disorders
Grade 3 CNS ischemia
|
0.33%
1/303
|
|
Nervous system disorders
Grade 4 CNS ischemia
|
0.99%
3/303
|
|
Nervous system disorders
Grade 3 Confusion
|
5.3%
16/303
|
|
Nervous system disorders
Grade 4 Confusion
|
1.3%
4/303
|
|
Nervous system disorders
Grade 3 Dizziness (includes lightneadedness, disequilibrium & vertigo)
|
9.6%
29/303
|
|
Nervous system disorders
Grade 4 Dizziness (includes lightheadedness, disequilibrium & vertigo)
|
1.3%
4/303
|
|
Nervous system disorders
Grade 3 Encephalopathy
|
0.33%
1/303
|
|
Nervous system disorders
Grade 3 Involuntary movement
|
0.66%
2/303
|
|
Nervous system disorders
Grade 3 Irritability
|
0.33%
1/303
|
|
Nervous system disorders
Grade 4 Memory impairment
|
0.33%
1/303
|
|
Nervous system disorders
Grade 3 Mental status
|
0.99%
3/303
|
|
Nervous system disorders
Grade 3 Mood alteration (agitation, anxiety, depression, euphoria)
|
7.3%
22/303
|
|
Nervous system disorders
Grade 4 Mood alteration (agitation, anxiety, depression, euphoria)
|
0.99%
3/303
|
|
Nervous system disorders
Grade 3 Mood/conscious change
|
0.33%
1/303
|
|
Nervous system disorders
Grade 3 Neurology-other
|
0.66%
2/303
|
|
Nervous system disorders
Grade 3 Neuropathy-motor
|
23.4%
71/303
|
|
Nervous system disorders
Grade 4 Neuropathy-motor
|
3.0%
9/303
|
|
Nervous system disorders
Grade 3 Psychosis
|
0.99%
3/303
|
|
Nervous system disorders
Grade 3 Seizure
|
0.99%
3/303
|
|
Nervous system disorders
Grade 3 Sensory Neuropathy
|
24.1%
73/303
|
|
Nervous system disorders
Grade 4 Sensory neuropathy
|
1.7%
5/303
|
|
Nervous system disorders
Grade 3 Somnolence
|
2.6%
8/303
|
|
Nervous system disorders
Grade 4 Somnolence
|
0.66%
2/303
|
|
Nervous system disorders
Grade 3 Syncope
|
9.9%
30/303
|
|
Nervous system disorders
Grade 4 Syncope
|
0.33%
1/303
|
|
Nervous system disorders
Grade 3 Tremor
|
2.0%
6/303
|
|
Nervous system disorders
Grade 3 Weakness-motor neuropathy
|
0.33%
1/303
|
|
Eye disorders
Grade 3 Blurred vision
|
2.6%
8/303
|
|
Eye disorders
Grade 3 Cataract
|
2.0%
6/303
|
|
Eye disorders
Grade 3 Flashing lights
|
0.33%
1/303
|
|
Eye disorders
Grade 3 Ocular-other
|
0.33%
1/303
|
|
Eye disorders
Grade 3 Photophobia
|
0.33%
1/303
|
|
Eye disorders
Grade 3 Retinal detachment
|
0.33%
1/303
|
|
General disorders
Grade 3 Abdomen NOS
|
4.0%
12/303
|
|
General disorders
Grade 3 Anus
|
0.33%
1/303
|
|
General disorders
Grade 3 Bone
|
2.0%
6/303
|
|
General disorders
Grade 3 Buttock
|
0.66%
2/303
|
|
General disorders
Grade 3 Cardiac/heart
|
0.99%
3/303
|
|
General disorders
Grade 3 Chest/thorax NOS
|
1.3%
4/303
|
|
General disorders
Grade 3 Chest wall
|
0.66%
2/303
|
|
General disorders
Grade 3 Esophagus
|
0.66%
2/303
|
|
General disorders
Grade 3 External ear
|
0.33%
1/303
|
|
General disorders
Grade 3 Extremity/limb
|
5.9%
18/303
|
|
General disorders
Grade 4 Extremity/limb
|
0.33%
1/303
|
|
General disorders
Grade 3 Face
|
0.33%
1/303
|
|
General disorders
Grade 3 Head/headache
|
3.6%
11/303
|
|
General disorders
Grade 3 Hip-left
|
1.3%
4/303
|
|
General disorders
Grade 3 Hip-right
|
1.7%
5/303
|
|
General disorders
Grade 3 Joint
|
1.7%
5/303
|
|
General disorders
Grade 4 Joint
|
0.33%
1/303
|
|
General disorders
Grade 3 Kidney
|
0.33%
1/303
|
|
General disorders
Grade 3 Lower back
|
4.6%
14/303
|
|
General disorders
Grade 4 Lower back
|
1.3%
4/303
|
|
General disorders
Grade 3 Middle back
|
5.0%
15/303
|
|
General disorders
Grade 3 Muscle
|
2.0%
6/303
|
|
General disorders
Grade 3 Neck
|
2.0%
6/303
|
|
General disorders
Grade 3 Neuralgia/peripheral nerve
|
0.66%
2/303
|
|
General disorders
Grade 3 Oral cavity
|
0.66%
2/303
|
|
General disorders
Grade 3 Pain NOS
|
4.0%
12/303
|
|
General disorders
Grade 3 Pleura
|
0.66%
2/303
|
|
General disorders
Grade 3 Rectum
|
0.33%
1/303
|
|
General disorders
Grade 3 Rib
|
0.66%
2/303
|
|
General disorders
Grade 3 Sinus
|
0.33%
1/303
|
|
General disorders
Grade 3 Skin
|
0.33%
1/303
|
|
General disorders
Grade 3 Stomach
|
1.7%
5/303
|
|
General disorders
Grade 3 Throat pharynx/larynx
|
1.7%
5/303
|
|
General disorders
Grade 4 Throat pharynx/larynx
|
0.33%
1/303
|
|
General disorders
Grade 3 Tumor pain
|
0.66%
2/303
|
|
General disorders
Grade 4 Tumor pain
|
0.33%
1/303
|
|
General disorders
Grade 3 Upper back
|
8.6%
26/303
|
|
General disorders
Grade 4 Upper back
|
0.99%
3/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 ARDS
|
1.3%
4/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 5 Atelectasis
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Cough
|
4.6%
14/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 DLCO
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Dyspnea
|
9.2%
28/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Dyspnea
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Hiccoughs
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Hypoxia
|
19.1%
58/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Hypoxia
|
0.66%
2/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 5 Hypoxia
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pneumonitis
|
7.3%
22/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Pneumonitis
|
0.66%
2/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pneumothorax
|
0.66%
2/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Pneumothorax
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Prolonged intubation
|
0.33%
1/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pulmonary-other
|
4.0%
12/303
|
|
Renal and urinary disorders
Grade 3 Bladder spasms
|
0.66%
2/303
|
|
Renal and urinary disorders
Grade 4 Bladder spasms
|
0.33%
1/303
|
|
Renal and urinary disorders
Grade 3 Creatinine increase
|
7.6%
23/303
|
|
Renal and urinary disorders
Grade 4 Creatinine increase
|
3.3%
10/303
|
|
Renal and urinary disorders
Grade 3 GU fistula-bladder
|
0.33%
1/303
|
|
Renal and urinary disorders
Grade 3 Incontinence-urinary
|
3.0%
9/303
|
|
Renal and urinary disorders
Grade 3 Renal failure
|
2.3%
7/303
|
|
Renal and urinary disorders
Grade 4 Renal failure
|
1.7%
5/303
|
|
Renal and urinary disorders
Grade 3 Renal-other
|
2.0%
6/303
|
|
Renal and urinary disorders
Grade 3 Urinary frequency/urgency
|
4.3%
13/303
|
|
Renal and urinary disorders
Grade 3 Urinary retention
|
0.33%
1/303
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Grade 3 Secondary malignancy
|
0.66%
2/303
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Grade 4 Secondary malignancy
|
0.66%
2/303
|
|
Reproductive system and breast disorders
Grade 3 Sexual-other
|
0.33%
1/303
|
|
Surgical and medical procedures
Grade 3 HN Operative Injury-neck
|
0.33%
1/303
|
|
Surgical and medical procedures
Grade 3 Muscle operative Injury-joint
|
0.33%
1/303
|
|
Surgical and medical procedures
Grade 3 Operative Injury-other
|
0.66%
2/303
|
|
Vascular disorders
Grade 3 Thrombosis/embolism
|
15.8%
48/303
|
|
Vascular disorders
Grade 4 Thrombosis/embolism
|
1.7%
5/303
|
|
Vascular disorders
Grade 3 Thrombosis/embolism (vasc acc)
|
1.7%
5/303
|
|
Vascular disorders
Grade 4 Thrombosis/embolism (vasc acc)
|
0.33%
1/303
|
Other adverse events
| Measure |
Study Treatment
n=303 participants at risk
Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
|
|---|---|
|
Immune system disorders
Grade 1 Allergic reaction/hypersensitivity
|
22.8%
69/303
|
|
Immune system disorders
Grade 2 Allergic reaction/hypersensitivity
|
8.9%
27/303
|
|
Immune system disorders
Grade 1 Rhinitis
|
14.2%
43/303
|
|
Immune system disorders
Grade 2 Rhinitis
|
6.3%
19/303
|
|
Ear and labyrinth disorders
Grade 1 Auditory/ear-other
|
5.3%
16/303
|
|
Ear and labyrinth disorders
Grade 2 Hearing w/o monitoring program
|
5.3%
16/303
|
|
Ear and labyrinth disorders
Grade 2 Tinnitus
|
10.2%
31/303
|
|
Blood and lymphatic system disorders
Grade 2 Anemia
|
37.0%
112/303
|
|
Cardiac disorders
Grade 1 Ventricular Arrythmia
|
17.2%
52/303
|
|
Cardiac disorders
Grade 2 Ventricular Arrythmia
|
19.1%
58/303
|
|
General disorders
Grade 1 Constitutional symptoms-other
|
15.8%
48/303
|
|
General disorders
Grade 2 Constitutional symptoms-other
|
5.6%
17/303
|
|
General disorders
Grade 2 Fatigue (lethargy, malaise, asthenia)
|
27.7%
84/303
|
|
General disorders
Grade 1 Fever (absence of neutropenia)
|
43.2%
131/303
|
|
General disorders
Grade 2 Fever (absence of neutropenia)
|
27.1%
82/303
|
|
General disorders
Grade 1 Insomnia
|
17.5%
53/303
|
|
General disorders
Grade 2 Insomnia
|
8.6%
26/303
|
|
General disorders
Grade 1 Rigors/chills
|
15.5%
47/303
|
|
General disorders
Grade 1 Sweating
|
17.8%
54/303
|
|
General disorders
Grade 2 Sweating
|
7.3%
22/303
|
|
General disorders
Grade 1 Weight loss
|
5.6%
17/303
|
|
General disorders
Grade 1 Weight gain
|
14.5%
44/303
|
|
Skin and subcutaneous tissue disorders
Grade 1 Alopecia
|
7.3%
22/303
|
|
Skin and subcutaneous tissue disorders
Grade 2 Alopecia
|
20.1%
61/303
|
|
Skin and subcutaneous tissue disorders
Grade 1 Dermatology-other
|
12.5%
38/303
|
|
Skin and subcutaneous tissue disorders
Grade 2 Dermatology-other
|
5.9%
18/303
|
|
Skin and subcutaneous tissue disorders
Grade 1 Dry skin
|
16.5%
50/303
|
|
Skin and subcutaneous tissue disorders
Grade 2 Dry skin
|
9.2%
28/303
|
|
Skin and subcutaneous tissue disorders
Grade 1 Flushing
|
5.6%
17/303
|
|
Skin and subcutaneous tissue disorders
Grade 1 Pruritus
|
5.9%
18/303
|
|
Skin and subcutaneous tissue disorders
Grade 1 Skin rash/desquamation
|
33.0%
100/303
|
|
Skin and subcutaneous tissue disorders
Grade 2 Skin rash/desquamation
|
27.1%
82/303
|
|
Endocrine disorders
Grade 1 Hot flashes
|
5.0%
15/303
|
|
Endocrine disorders
Grade 2 Hypothyroidism
|
7.3%
22/303
|
|
Gastrointestinal disorders
Grade 1 Anorexia
|
8.9%
27/303
|
|
Gastrointestinal disorders
Grade 2 Anorexia
|
43.9%
133/303
|
|
Gastrointestinal disorders
Grade 1 Colitis
|
12.2%
37/303
|
|
Gastrointestinal disorders
Grade 2 Colitis
|
11.6%
35/303
|
|
Gastrointestinal disorders
Grade 1 Constipation
|
40.3%
122/303
|
|
Gastrointestinal disorders
Grade 2 Constipation
|
35.3%
107/303
|
|
Gastrointestinal disorders
Grade 1 Dehydration
|
5.0%
15/303
|
|
Gastrointestinal disorders
Grade 2 Dehydration
|
9.9%
30/303
|
|
Gastrointestinal disorders
Grade 1 Diarrhea
|
21.8%
66/303
|
|
Gastrointestinal disorders
Grade 2 Diarrhea
|
36.6%
111/303
|
|
Gastrointestinal disorders
Grade 1 Dry mouth
|
15.5%
47/303
|
|
Gastrointestinal disorders
Grade 2 Dry mouth
|
6.9%
21/303
|
|
Gastrointestinal disorders
Grade 1 Dysphagisa
|
10.9%
33/303
|
|
Gastrointestinal disorders
Grade 2 Dysphagia
|
18.5%
56/303
|
|
Gastrointestinal disorders
Grade 1 Esophagitis
|
7.6%
23/303
|
|
Gastrointestinal disorders
Grade 2 Esophagitis
|
21.5%
65/303
|
|
Gastrointestinal disorders
Grade 1 GI-other
|
10.9%
33/303
|
|
Gastrointestinal disorders
Grade 1 Heartburn
|
11.2%
34/303
|
|
Gastrointestinal disorders
Grade 1 Mucositis/Stomatitis
|
31.7%
96/303
|
|
Gastrointestinal disorders
Grade 2 Mucositis/Stomatitis
|
19.8%
60/303
|
|
Gastrointestinal disorders
Grade 1 Nausea
|
19.5%
59/303
|
|
Gastrointestinal disorders
Grade 2 Nausea
|
49.2%
149/303
|
|
Gastrointestinal disorders
Grade 1 Taste alteration
|
9.2%
28/303
|
|
Gastrointestinal disorders
Grade 2 Taste alteration
|
4.6%
14/303
|
|
Gastrointestinal disorders
Grade 1 Vomiting
|
22.4%
68/303
|
|
Gastrointestinal disorders
Grade 2 Vomiting
|
35.6%
108/303
|
|
Blood and lymphatic system disorders
Grade 1 Hemorrhage-lower GI
|
6.3%
19/303
|
|
Hepatobiliary disorders
Grade 1 Alkaline phosphatase increase
|
59.7%
181/303
|
|
Hepatobiliary disorders
Grade 2 Alkaline phosphatase increase
|
10.2%
31/303
|
|
Hepatobiliary disorders
Grade 1 Bilirubin increase
|
25.7%
78/303
|
|
Hepatobiliary disorders
Grade 2 Bilirubin increase
|
8.6%
26/303
|
|
Hepatobiliary disorders
Grade 1 Hypoalbuminemia
|
13.2%
40/303
|
|
Hepatobiliary disorders
Grade 2 Hypoalbuminemia
|
68.6%
208/303
|
|
Hepatobiliary disorders
Grade 1 SGOT (AST) increase
|
56.4%
171/303
|
|
Hepatobiliary disorders
Grade 2 SGOT (AST) increase
|
9.2%
28/303
|
|
Hepatobiliary disorders
Grade 1 SGPT (ALT) increase
|
55.4%
168/303
|
|
Hepatobiliary disorders
Grade 2 SGPT (ALT) increase
|
14.9%
45/303
|
|
Infections and infestations
Grade 2 Opportunistic infection
|
6.6%
20/303
|
|
Infections and infestations
Grade 2 Infection (documented clinically or microbiologically)
|
8.6%
26/303
|
|
Blood and lymphatic system disorders
Grade 1 Edema-head and neck
|
7.6%
23/303
|
|
Blood and lymphatic system disorders
Grade 1 Edema-limb
|
38.9%
118/303
|
|
Blood and lymphatic system disorders
Grade 2 Edema-limb
|
11.9%
36/303
|
|
Blood and lymphatic system disorders
Grade 1 Lymphatics-other
|
5.3%
16/303
|
|
Metabolism and nutrition disorders
Grade 1 Bicarbonate decrease
|
72.3%
219/303
|
|
Metabolism and nutrition disorders
Grade 2 Bicarbonate decrease
|
11.2%
34/303
|
|
Metabolism and nutrition disorders
Grade 1 Hypercalcemia
|
10.6%
32/303
|
|
Metabolism and nutrition disorders
Grade 1 Hyperglycemia
|
5.0%
15/303
|
|
Metabolism and nutrition disorders
Grade 2 Hyperglycemia
|
54.5%
165/303
|
|
Metabolism and nutrition disorders
Grade 1 Hyperkalemia
|
31.4%
95/303
|
|
Metabolism and nutrition disorders
Grade 2 Hyperkalemia
|
11.2%
34/303
|
|
Metabolism and nutrition disorders
Grade 1 Hypermagnesemia
|
10.2%
31/303
|
|
Metabolism and nutrition disorders
Grade 1 Hypernatremia
|
16.2%
49/303
|
|
Metabolism and nutrition disorders
Grade 2 Hypocalcemia
|
49.8%
151/303
|
|
Metabolism and nutrition disorders
Grade 1 Hypokalemia
|
53.5%
162/303
|
|
Metabolism and nutrition disorders
Grade 1 Hypomagnesemia
|
24.8%
75/303
|
|
Metabolism and nutrition disorders
Grade 2 Hypomagnesemia
|
11.9%
36/303
|
|
Metabolism and nutrition disorders
Grade 1 Hyponatremia
|
34.3%
104/303
|
|
Metabolism and nutrition disorders
Grade 2 Hypophosphatemia
|
17.8%
54/303
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Gait/walking
|
5.9%
18/303
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Joint-function
|
5.0%
15/303
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Muscle weakness-whole body
|
11.6%
35/303
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Muscle weakness-whole body
|
9.6%
29/303
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Musculoskeletal-other
|
15.2%
46/303
|
|
Nervous system disorders
Grade 1 Confusion
|
21.8%
66/303
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Confusion
|
8.6%
26/303
|
|
Nervous system disorders
Grade 1 Dizziness
|
31.7%
96/303
|
|
Nervous system disorders
Grade 2 Dizziness
|
23.8%
72/303
|
|
Nervous system disorders
Grade 1 Memory impairment
|
7.3%
22/303
|
|
Nervous system disorders
Grade 2 Memory impairment
|
4.6%
14/303
|
|
Nervous system disorders
Grade 1 Mood alteration
|
32.7%
99/303
|
|
Nervous system disorders
Grade 2 Mood alteration
|
32.0%
97/303
|
|
Nervous system disorders
Grade 1 Neurology-other
|
5.3%
16/303
|
|
Nervous system disorders
Grade 1 Neuropathy-motor
|
24.4%
74/303
|
|
Nervous system disorders
Grade 2 Neuropathy-motor
|
27.7%
84/303
|
|
Nervous system disorders
Grade 1 Sensory -neuropathy
|
25.4%
77/303
|
|
Nervous system disorders
Grade 2 Sensory-neuropathy
|
38.9%
118/303
|
|
Nervous system disorders
Grade 2 Somnolence
|
9.2%
28/303
|
|
Nervous system disorders
Grade 1 Tremor
|
18.5%
56/303
|
|
Nervous system disorders
Grade 2 Tremor
|
8.9%
27/303
|
|
Eye disorders
Grade 1 Blurred vision
|
48.2%
146/303
|
|
Eye disorders
Grade 2 Blurred vision
|
10.6%
32/303
|
|
Eye disorders
Grade 1 Ocular-other
|
7.9%
24/303
|
|
General disorders
Grade 1 Abdomen
|
10.2%
31/303
|
|
General disorders
Grade 2 Bone
|
5.3%
16/303
|
|
General disorders
Grade 1 Chest-thorax
|
5.3%
16/303
|
|
General disorders
Grade 1 Chest wall
|
5.3%
16/303
|
|
General disorders
Grade 1 Extremity-limb
|
11.9%
36/303
|
|
General disorders
Grade 2 Extremity-limb
|
13.9%
42/303
|
|
General disorders
Grade 1 Head-headache
|
16.8%
51/303
|
|
General disorders
Grade 2 Head-headache
|
8.3%
25/303
|
|
General disorders
Grade 2 Hip-left
|
5.3%
16/303
|
|
General disorders
Grade 1 Joint
|
9.6%
29/303
|
|
General disorders
Grade 2 Joint
|
7.6%
23/303
|
|
General disorders
Grade 1 Lower back
|
11.6%
35/303
|
|
General disorders
Grade 2 Lower back
|
18.8%
57/303
|
|
General disorders
Grade 1 Middle back
|
10.6%
32/303
|
|
General disorders
Grade 2 Middle back
|
7.9%
24/303
|
|
General disorders
Grade 1 Muscle
|
5.9%
18/303
|
|
General disorders
Grade 1 Neck
|
5.6%
17/303
|
|
General disorders
Grade 1 Pain NOS
|
15.8%
48/303
|
|
General disorders
Grade 2 Pain NOS
|
8.9%
27/303
|
|
General disorders
Grade 1 Stomach
|
7.6%
23/303
|
|
General disorders
Grade 1 Throat pharynx-larynx
|
5.0%
15/303
|
|
General disorders
Grade 1 Upper back
|
18.8%
57/303
|
|
General disorders
Grade 2 Upper back
|
25.1%
76/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Cough
|
52.1%
158/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Cough
|
23.8%
72/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Dyspnea
|
15.2%
46/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Dyspnea
|
9.2%
28/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Hiccoughs
|
7.6%
23/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Hypoxia
|
21.8%
66/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Nasal/paranasal reactions
|
6.3%
19/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pneumonitis
|
6.6%
20/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Pulmonary-other
|
9.9%
30/303
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pulmonary-other
|
5.6%
17/303
|
|
Renal and urinary disorders
Grade 1 Creatinine increase
|
37.0%
112/303
|
|
Renal and urinary disorders
Grade 2 Creatinine increase
|
20.5%
62/303
|
|
Renal and urinary disorders
Grade 1 Incontinence-urinary
|
8.9%
27/303
|
|
Renal and urinary disorders
Grade 2 Incontinence-urinary
|
5.6%
17/303
|
|
Renal and urinary disorders
Grade 1 Renal-other
|
7.6%
23/303
|
|
Renal and urinary disorders
Grade 1 Urinary frequency-urgency
|
24.8%
75/303
|
|
Renal and urinary disorders
Grade 2 Urinary frequency-urgency
|
8.9%
27/303
|
|
Vascular disorders
Grade 2 Thrombosis/embolism
|
9.6%
29/303
|
Additional Information
Director of Clinical Trials and Regulatory Affairs
The Myeloma Institute, University of Arkansas for Medical Sciences
Phone: 501-526-6990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place