Trial Outcomes & Findings for Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM) (NCT NCT00617591)
NCT ID: NCT00617591
Last Updated: 2014-01-17
Results Overview
ORR assessed using International Myeloma Working Group Response Definitions. Partial Remission (PR): A greater than 50% reduction in the serum paraprotein, and if present, a greater than 90% reduction in the urine M protein excretion. Patients must also have a decrease by 50% in the size of soft tissue plasmacytoma. If serum and urine M protein are not measurable, a 50% or greater decreased in the difference of the involved and uninvolved free light chain. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
24 Months
Results posted on
2014-01-17
Participant Flow
57 Eligible participants were enrolled at Moffitt Cancer Center between February 2008 and February 2011.
Participant milestones
| Measure |
Induction and Maintenance Therapy
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Induction and Maintenance Therapy
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Overall Study
Withdrew consent during Induction
|
4
|
|
Overall Study
Withdrew consent during Maintenance
|
6
|
Baseline Characteristics
Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM)
Baseline characteristics by cohort
| Measure |
Induction and Maintenance Therapy
n=57 Participants
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: All participants
ORR assessed using International Myeloma Working Group Response Definitions. Partial Remission (PR): A greater than 50% reduction in the serum paraprotein, and if present, a greater than 90% reduction in the urine M protein excretion. Patients must also have a decrease by 50% in the size of soft tissue plasmacytoma. If serum and urine M protein are not measurable, a 50% or greater decreased in the difference of the involved and uninvolved free light chain. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.
Outcome measures
| Measure |
Induction and Maintenance Therapy
n=57 Participants
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Overall Response Rate (ORR) - Percentage of Participants With Partial Response or Better With Induction Regimen
|
77.2 percentage of participants
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: All participants
Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction Dd-R as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.
Outcome measures
| Measure |
Induction and Maintenance Therapy
n=57 Participants
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Percentage of Participants With Very Good Partial Remission (VGPR) or Better
|
42.1 percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: All participants
PFS: Time from study entry to progression/relapse or death from study entry to death of any cause, assessed using International Myeloma Working Group Response Definitions. Progressive Disease (PD): One of the following criteria must be met: a. Increase of 25% or greater in serum M protein (absolute increase greater or equal to 0.5g/dl); b. Increase of 25% or greater in urine M protein (absolute increase greater than 200 mg/24h); c. Increase of 25% or greater in the difference between the involved and uninvolved free light chain (absolute increase greater than 10 mg/dl); d. Increase of 25% or greater in bone marrow plasma cell percentage (absolute percent greater than 5% in case the patient was in CR and 10% otherwise); i.e. Definite development of new bone lesions or soft tissue plasmacytomas, or increase in the size of existing plasmacytomas by greater or equal to 25%. Development of hypercalcemia (serum calcium \> 11.5 mg/dl) attributable only to the plasma cell dyscrasia.
Outcome measures
| Measure |
Induction and Maintenance Therapy
n=57 Participants
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Median Progression Free Survival (PFS) in Months
|
28 months
Interval 18.1 to 34.8
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: All participants
Percentage of participants with Overall Survival in response to Dd-R in newly diagnosed multiple myeloma patients with active disease. Overall survival is time from study entry to death of any cause.
Outcome measures
| Measure |
Induction and Maintenance Therapy
n=57 Participants
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
2 Year Overall Survival (OS) Rate
|
79.6 percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: First 29 participants with the PLD starting dose of PLD 40 mg/m\^2, due to increased neutropenia and fatigue.
Tolerability of full dose Revlimid® with full dose Doxil® in combination with reduced schedule dexamethasone was to be assessed during Cycle 1 and at the start of Cycle 2 using, whenever possible, the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0. Due to increased neutropenia and fatigue, toxicities were reviewed after the first 29 participants were enrolled.
Outcome measures
| Measure |
Induction and Maintenance Therapy
n=29 Participants
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Occurrence of Induction Toxicities
Percentage with Dose Reductions Required
|
24 percentage of participants
|
|
Occurrence of Induction Toxicities
Percentage Receiving < 4 Cycles of Therapy
|
20 percentage of participants
|
|
Occurrence of Induction Toxicities
Percentage Who Discontinued After Only 1 Cycle
|
13.79 percentage of participants
|
|
Occurrence of Induction Toxicities
Percentage with Grade 3/4 Neutropenia
|
48 percentage of participants
|
|
Occurrence of Induction Toxicities
Percentage with Grade 3/4 Fatigue
|
20 percentage of participants
|
Adverse Events
Induction and Maintenance Therapy
Serious events: 26 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction and Maintenance Therapy
n=57 participants at risk
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Cardiac disorders
Palpitations
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Cardiac disorders
Cardiac General - Other
|
3.5%
2/57 • Number of events 2 • 4 years, 10 months
|
|
General disorders
Constitutional Symptoms - Other
|
3.5%
2/57 • Number of events 2 • 4 years, 10 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)
|
7.0%
4/57 • Number of events 6 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.5%
2/57 • Number of events 2 • 4 years, 10 months
|
|
Gastrointestinal disorders
Dehydration
|
1.8%
1/57 • Number of events 2 • 4 years, 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/57 • Number of events 2 • 4 years, 10 months
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Febrile neutropenia
|
3.5%
2/57 • Number of events 2 • 4 years, 10 months
|
|
Infections and infestations
Infection(documented clinically or microbiologically) w/Grade 3 or 4 neutrophils - Lung(pneumonia)
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Sinus
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Infection - Other
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
3.5%
2/57 • Number of events 2 • 4 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
7.0%
4/57 • Number of events 4 • 4 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Psychiatric disorders
Confusion
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
General disorders
Pain - NOS
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
7.0%
4/57 • Number of events 4 • 4 years, 10 months
|
|
Renal and urinary disorders
Renal failure
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
General disorders
Syndromes - Other
|
1.8%
1/57 • Number of events 1 • 4 years, 10 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.0%
4/57 • Number of events 4 • 4 years, 10 months
|
Other adverse events
| Measure |
Induction and Maintenance Therapy
n=57 participants at risk
Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
|
|---|---|
|
General disorders
Fatigue
|
61.4%
35/57 • Number of events 60 • 4 years, 10 months
|
|
General disorders
Sweating (diaphoresis)
|
29.8%
17/57 • Number of events 17 • 4 years, 10 months
|
|
General disorders
Fever (in the absence of neutropenia)
|
22.8%
13/57 • Number of events 15 • 4 years, 10 months
|
|
General disorders
Insomnia
|
24.6%
14/57 • Number of events 16 • 4 years, 10 months
|
|
General disorders
Rigors/chills
|
21.1%
12/57 • Number of events 14 • 4 years, 10 months
|
|
General disorders
Weight Loss
|
7.0%
4/57 • Number of events 4 • 4 years, 10 months
|
|
Gastrointestinal disorders
Constipation
|
43.9%
25/57 • Number of events 35 • 4 years, 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
42.1%
24/57 • Number of events 32 • 4 years, 10 months
|
|
Gastrointestinal disorders
Nausea
|
40.4%
23/57 • Number of events 33 • 4 years, 10 months
|
|
Gastrointestinal disorders
Anorexia
|
29.8%
17/57 • Number of events 20 • 4 years, 10 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
14.0%
8/57 • Number of events 15 • 4 years, 10 months
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
12/57 • Number of events 17 • 4 years, 10 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
21.1%
12/57 • Number of events 16 • 4 years, 10 months
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
12.3%
7/57 • Number of events 7 • 4 years, 10 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.5%
6/57 • Number of events 6 • 4 years, 10 months
|
|
Gastrointestinal disorders
Dehydration
|
8.8%
5/57 • Number of events 6 • 4 years, 10 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland
|
7.0%
4/57 • Number of events 4 • 4 years, 10 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
8.8%
5/57 • Number of events 5 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
73.7%
42/57 • Number of events 238 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
71.9%
41/57 • Number of events 244 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
43.9%
25/57 • Number of events 82 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Platelets
|
45.6%
26/57 • Number of events 111 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.8%
5/57 • Number of events 20 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
36.8%
21/57 • Number of events 30 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
15.8%
9/57 • Number of events 14 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
8.8%
5/57 • Number of events 5 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
14.0%
8/57 • Number of events 10 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
8.8%
5/57 • Number of events 10 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
8.8%
5/57 • Number of events 6 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
7.0%
4/57 • Number of events 5 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
7.0%
4/57 • Number of events 4 • 4 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
3/57 • Number of events 4 • 4 years, 10 months
|
|
General disorders
Pain - Head/headache
|
19.3%
11/57 • Number of events 11 • 4 years, 10 months
|
|
General disorders
Pain - Extremity-limb
|
8.8%
5/57 • Number of events 6 • 4 years, 10 months
|
|
General disorders
Pain - Abdomen NOS
|
8.8%
5/57 • Number of events 5 • 4 years, 10 months
|
|
General disorders
Pain - Throat/pharynx/larynx
|
7.0%
4/57 • Number of events 6 • 4 years, 10 months
|
|
General disorders
Pain - Joint
|
5.3%
3/57 • Number of events 5 • 4 years, 10 months
|
|
General disorders
Pain - Muscle
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
General disorders
Pain - Oral cavity
|
7.0%
4/57 • Number of events 5 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
29.8%
17/57 • Number of events 18 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
9/57 • Number of events 10 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
10.5%
6/57 • Number of events 7 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
10.5%
6/57 • Number of events 9 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
General disorders
Dizziness
|
21.1%
12/57 • Number of events 12 • 4 years, 10 months
|
|
Nervous system disorders
Neuropathy: sensory
|
22.8%
13/57 • Number of events 16 • 4 years, 10 months
|
|
Psychiatric disorders
Mood alteration - Depression
|
12.3%
7/57 • Number of events 7 • 4 years, 10 months
|
|
Nervous system disorders
Neurology - Other
|
10.5%
6/57 • Number of events 6 • 4 years, 10 months
|
|
Nervous system disorders
Syncope (fainting)
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Nervous system disorders
Tremor
|
12.3%
7/57 • Number of events 7 • 4 years, 10 months
|
|
Nervous system disorders
Neuropathy: motor
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
50.9%
29/57 • Number of events 44 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
5.3%
3/57 • Number of events 5 • 4 years, 10 months
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
5.3%
3/57 • Number of events 4 • 4 years, 10 months
|
|
Infections and infestations
Febrile neutropenia
|
14.0%
8/57 • Number of events 11 • 4 years, 10 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
17.5%
10/57 • Number of events 16 • 4 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
15.8%
9/57 • Number of events 10 • 4 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Immune system disorders
Allergic rhinitis
|
14.0%
8/57 • Number of events 8 • 4 years, 10 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.8%
5/57 • Number of events 8 • 4 years, 10 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.3%
3/57 • Number of events 10 • 4 years, 10 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Cardiac disorders
Hypotension
|
12.3%
7/57 • Number of events 11 • 4 years, 10 months
|
|
Eye disorders
Ocular/Visual - Other
|
8.8%
5/57 • Number of events 5 • 4 years, 10 months
|
|
Eye disorders
Dry eye syndrome
|
5.3%
3/57 • Number of events 3 • 4 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
8.8%
5/57 • Number of events 5 • 4 years, 10 months
|
|
General disorders
Flu-like syndrome
|
7.0%
4/57 • Number of events 5 • 4 years, 10 months
|
Additional Information
Rachid Baz, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-8212
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place