Trial Outcomes & Findings for Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma (NCT NCT01062230)
NCT ID: NCT01062230
Last Updated: 2015-04-06
Results Overview
All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Baseline and Day 1
Results posted on
2015-04-06
Participant Flow
Participant milestones
| Measure |
All Patients
All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
All Patients
n=6 Participants
All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles.
|
|---|---|
|
Age, Continuous
|
71 Years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 1All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.
Outcome measures
| Measure |
All Patients
n=6 Participants
All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles.
|
|---|---|
|
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
Subject 1
|
113.5 % change
|
|
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
Subject 2
|
-9.09 % change
|
|
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
Subject 3
|
30.7 % change
|
|
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
Subject 4
|
-50 % change
|
|
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
Subject 5
|
93.6 % change
|
|
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
Subject 6
|
-53.5 % change
|
Adverse Events
All Patients
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Patients
n=6 participants at risk
All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles.
|
|---|---|
|
Metabolism and nutrition disorders
hypercalcemia
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
platelets
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine, Serum
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Low ANC
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
platelets - Thrombocytopenia
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Albumin - hypoalbuminemia
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
hemoglobin
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Weak pulse
|
16.7%
1/6 • Number of events 1
|
Additional Information
Maurizio Zangari, MD Principal Investigator
Huntsman Cancer Institute at the University of Utah Medical Center
Phone: 801-585-3229
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place