Trial Outcomes & Findings for Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma (NCT NCT00075881)
NCT ID: NCT00075881
Last Updated: 2014-06-02
Results Overview
Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days
Results posted on
2014-06-02
Participant Flow
The study was activated on January 16, 2004 and terminated on March 7, 2005 after 44 patients had enrolled. Accrual rate was 3 patients per month, slower than expected rate (6 patients per month)
Participant milestones
| Measure |
PS-341
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
Eligible
|
43
|
|
Overall Study
Treated
|
42
|
|
Overall Study
Induction Treatment
|
42
|
|
Overall Study
Maintenance Treatment
|
15
|
|
Overall Study
Reinduction Treatment
|
7
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
PS-341
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
18
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
other complicating disease
|
3
|
|
Overall Study
other
|
4
|
|
Overall Study
missing data
|
2
|
|
Overall Study
Ineligible
|
1
|
|
Overall Study
never start protocol therapy
|
1
|
Baseline Characteristics
Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
PS-341
n=42 Participants
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 daysPopulation: 42 eligible and treated patients were included in the analysis.
Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
PS-341
n=42 Participants
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Response Rate on Induction
|
47.6 percentage of participants
Interval 34.2 to 61.3
|
SECONDARY outcome
Timeframe: participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 daysPopulation: 15 eligible and treated patients were included in the analysis.
ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 15 eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
PS-341
n=15 Participants
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Response Rate on Maintenance
|
66.7 percentage of participants
Interval 42.3 to 85.8
|
SECONDARY outcome
Timeframe: participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 daysPopulation: 7 eligible and treated patients were included in the analysis.
ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 7 eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
PS-341
n=7 Participants
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Response Rate on Reinduction
|
28.6 percentage of participants
Interval 5.4 to 65.9
|
SECONDARY outcome
Timeframe: Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entryPopulation: 42 eligible and treated patients
Progression-free survival is defined as time from randomization to disease progression or death from any cause, whichever occurred first. Disease progression is defined using the ECOG Myeloma Response Criteria. Kaplan-Meier method is used to estimate the 1-year progression-free survival probability. 42 eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
PS-341
n=42 Participants
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
1-year Progression Free Survival Probability
|
36.4 percentage of participants
Interval 19.4 to 53.7
|
Adverse Events
PS-341
Serious events: 37 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PS-341
n=43 participants at risk
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
27.9%
12/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Leukopenia
|
20.9%
9/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Neutropenia
|
32.6%
14/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Thrombocytopenia
|
18.6%
8/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Cardiac disorders
Heart block asystole
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Cardiac disorders
Sinus bradycardia
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Vasovagal episode
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Cardiac disorders
Cardiac-other
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
General disorders
Fatigue
|
16.3%
7/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Weight loss
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Anorexia
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Constipation
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Dehydration
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
23.3%
10/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Obstruction, small bowel NOS
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Infections and infestations
Infection-other
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
General disorders
Edema limb
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Alkaline phosphatase increased
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Boold amylase increased
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Bilirubin increased
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Creatinine increased
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.3%
4/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.9%
9/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Psychiatric disorders
Confusion
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Dizziness/lightheadedness
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Neuropathy-sensory
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Syncope
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Abonominal pain
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Neuropathic pain
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
2/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
2.3%
1/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
Other adverse events
| Measure |
PS-341
n=43 participants at risk
Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
88.4%
38/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Leukopenia
|
62.8%
27/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Neutropenia
|
62.8%
27/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Thrombocytopenia
|
72.1%
31/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Vascular disorders
Hypertension
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Vascular disorders
Hypotension
|
14.0%
6/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
General disorders
Fatigue
|
67.4%
29/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
General disorders
Fever w/o neutropenia
|
14.0%
6/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Weight loss
|
14.0%
6/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.3%
4/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
23.3%
10/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Anorexia
|
51.2%
22/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Constipation
|
44.2%
19/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
4/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
32.6%
14/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Nausea
|
60.5%
26/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Taste disturbance
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
10/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
General disorders
Edema limb
|
14.0%
6/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Alkaline phosphatase increased
|
39.5%
17/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
25.6%
11/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
34.9%
15/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Bilirubin increased
|
23.3%
10/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.3%
4/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
53.5%
23/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Investigations
Creatinine increased
|
44.2%
19/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.3%
10/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.2%
13/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.6%
5/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Metabolism and nutrition disorders
Hyponatremia
|
46.5%
20/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Dizziness/lightheadedness
|
27.9%
12/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Neuropathy-motor
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Neuropathy-sensory
|
58.1%
25/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Gastrointestinal disorders
Abonominal pain
|
18.6%
8/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Headache
|
7.0%
3/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Musculoskeletal and connective tissue disorders
Join pain
|
23.3%
10/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
25.6%
11/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Nervous system disorders
Neuropathic pain
|
14.0%
6/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.0%
6/43 • Reported at the end of each cycle on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-6 years of study entry
1 cycle = 21 days for induction and re-induction, 1 cycle=28 days for maintenance
|
Additional Information
Study Statistician
Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60