Trial Outcomes & Findings for Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients (NCT NCT00536575)
NCT ID: NCT00536575
Last Updated: 2013-02-27
Results Overview
The percentage of patients who experience an objective benefit from treatment, determined by the treating physician after reviewing key laboratory values from blood and urine.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
24 months
Results posted on
2013-02-27
Participant Flow
Participant milestones
| Measure |
Sorafenib/Bortezomib
The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Sorafenib/Bortezomib
The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients
Baseline characteristics by cohort
| Measure |
Sorafenib/Bortezomib
n=13 Participants
The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
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|---|---|
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Age Continuous
|
67 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe percentage of patients who experience an objective benefit from treatment, determined by the treating physician after reviewing key laboratory values from blood and urine.
Outcome measures
| Measure |
Sorafenib/Bortezomib
n=11 Participants
The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
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|---|---|
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Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
15 percentage of participants
|
Adverse Events
Sorafenib/Bortezomib
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib/Bortezomib
n=13 participants at risk
The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
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|---|---|
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Cardiac disorders
Cardiopulmonary Arrest
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Death
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Infection - Pneumonia
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Sorafenib/Bortezomib
n=13 participants at risk
The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
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|---|---|
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Metabolism and nutrition disorders
Alkaline Phosphatase
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
2/13 • Number of events 3
|
|
General disorders
Amyloidosis
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
38.5%
5/13 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
3/13 • Number of events 11
|
|
Metabolism and nutrition disorders
Bilirubin
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Cold Symptoms
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • Number of events 6
|
|
General disorders
Death
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
23.1%
3/13 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
30.8%
4/13 • Number of events 11
|
|
General disorders
Disease Progression
|
7.7%
1/13 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 4
|
|
Eye disorders
Dry Eye
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Number of events 2
|
|
Blood and lymphatic system disorders
Edema
|
23.1%
3/13 • Number of events 4
|
|
Metabolism and nutrition disorders
Creatinine
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
76.9%
10/13 • Number of events 29
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Flushing
|
100.0%
1/1 • Number of events 1
|
|
Eye disorders
Glaucoma
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
38.5%
5/13 • Number of events 8
|
|
Gastrointestinal disorders
Heartburn
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
69.2%
9/13 • Number of events 26
|
|
Blood and lymphatic system disorders
Hemorrhage
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.4%
2/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
30.8%
4/13 • Number of events 7
|
|
Blood and lymphatic system disorders
Hyperviscosity
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypogammaglobulinemia
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Infection - Other
|
46.2%
6/13 • Number of events 8
|
|
General disorders
Insomnia
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint - Effusion
|
7.7%
1/13 • Number of events 1
|
|
Immune system disorders
Leukocytes
|
53.8%
7/13 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other
|
23.1%
3/13 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Number of events 9
|
|
Nervous system disorders
Altered mental status
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Neuropathy - Motor
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Neuropathy - Peripheral
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Neuropathy - Sensory
|
46.2%
6/13 • Number of events 17
|
|
Immune system disorders
Neutrophils
|
38.5%
5/13 • Number of events 11
|
|
Eye disorders
Ocular - Other
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Pain - Other (cramp)
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - Headache
|
15.4%
2/13 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
38.5%
5/13 • Number of events 9
|
|
General disorders
Somnolence
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Supraventricular Arrhythmia
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - Leg
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
53.8%
7/13 • Number of events 22
|
|
Renal and urinary disorders
Urinary Frequency
|
15.4%
2/13 • Number of events 4
|
|
Renal and urinary disorders
Urine Color Change
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 4
|
|
General disorders
Weakness
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Dry skin
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - abdomen
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - back
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Pain - bone
|
15.4%
2/13 • Number of events 3
|
|
General disorders
Pain - breast
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - chest
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - ear
|
7.7%
1/13 • Number of events 6
|
|
General disorders
Pain - Extremity-limb
|
53.8%
7/13 • Number of events 12
|
|
General disorders
Pain - joint
|
23.1%
3/13 • Number of events 5
|
|
General disorders
Pain - muscle
|
7.7%
1/13 • Number of events 2
|
|
General disorders
Pain - skin
|
7.7%
1/13 • Number of events 2
|
|
General disorders
Pain - teeth
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - throat
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain NOS
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus reaction
|
15.4%
2/13 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - other
|
15.4%
2/13 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER