Trial Outcomes & Findings for Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients (NCT NCT00983346)
NCT ID: NCT00983346
Last Updated: 2016-07-11
Results Overview
The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2016-07-11
Participant Flow
Participant milestones
| Measure |
Arm -1 Bortezomib
All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m\^2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients
Baseline characteristics by cohort
| Measure |
Arm -1 Bortezomib
n=17 Participants
All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m\^2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study
The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.
Outcome measures
| Measure |
Arm 1 Bortezomib
n=13 Participants
All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.
|
|---|---|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 1
|
178 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 3
|
105 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 4
|
105 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 6
|
99 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 7
|
95 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 8
|
119 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 10
|
128 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 11
|
84 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 13
|
125 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 14
|
120 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 15
|
96 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 16
|
98 Percentage of Baseline Value
|
|
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
% Base Line Patient 17
|
431 Percentage of Baseline Value
|
Adverse Events
Arm 1 Bortezomib
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 Bortezomib
n=17 participants at risk
All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Obstruction of airway
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
small bowel obstruction
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
Arm 1 Bortezomib
n=17 participants at risk
All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.
|
|---|---|
|
Gastrointestinal disorders
abdomen pain
|
11.8%
2/17 • Number of events 2
|
|
Immune system disorders
allergic reaction
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
altered mental status
|
5.9%
1/17 • Number of events 2
|
|
Nervous system disorders
anxiety
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.9%
1/17 • Number of events 3
|
|
Eye disorders
blurred vision
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
bruising
|
17.6%
3/17 • Number of events 3
|
|
Infections and infestations
Candida albicans
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
cardiomegaly
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
17.6%
3/17 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
depression
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
dizziness
|
11.8%
2/17 • Number of events 2
|
|
Eye disorders
dry eye syndrome
|
5.9%
1/17 • Number of events 1
|
|
Ear and labyrinth disorders
ear discomfort
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
edema
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated Ast
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
elevated Creatinine
|
17.6%
3/17 • Number of events 3
|
|
Blood and lymphatic system disorders
elevated Prothrombin time
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
erythema
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
falls
|
5.9%
1/17 • Number of events 1
|
|
General disorders
fatigue
|
41.2%
7/17 • Number of events 8
|
|
General disorders
finernail disocloration
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • Number of events 3
|
|
Infections and infestations
Herpes lesion
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated LDL
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated VLDL
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
11.8%
2/17 • Number of events 4
|
|
Metabolism and nutrition disorders
hyperglycemia
|
23.5%
4/17 • Number of events 5
|
|
Metabolism and nutrition disorders
hyperkalemia
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
35.3%
6/17 • Number of events 10
|
|
Nervous system disorders
Hypoesthesia
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.6%
3/17 • Number of events 3
|
|
Metabolism and nutrition disorders
hypophoasphatemia
|
17.6%
3/17 • Number of events 9
|
|
Cardiac disorders
hypotension
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
influenza
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
insomnia
|
17.6%
3/17 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Itching
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
11.8%
2/17 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
neck ecchymosis
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
neuopathy
|
29.4%
5/17 • Number of events 6
|
|
General disorders
night sweats
|
5.9%
1/17 • Number of events 1
|
|
General disorders
nipple swelling
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
5.9%
1/17 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ovarian cyst
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pruritus
|
5.9%
1/17 • Number of events 1
|
|
General disorders
elevated PSA
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
11.8%
2/17 • Number of events 2
|
|
Infections and infestations
sinus congestion
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
skin redness
|
5.9%
1/17 • Number of events 1
|
|
General disorders
sore throat
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Sublingual hematoma
|
5.9%
1/17 • Number of events 1
|
|
General disorders
sweating
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
tachycardia
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
29.4%
5/17 • Number of events 6
|
|
General disorders
toothache
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Yersinia enterocolitica
|
5.9%
1/17 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place