Trial Outcomes & Findings for Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma (NCT NCT00128921)

Results Overview

Parathyroid hormone: Any increase in PTH was considered response

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

6 months

Results posted on

2012-04-26

Participant Flow

Recruitment was between 4/17/2006 to 11/26/2007. The Recruitment occurred in the Myeloma outpatient clinic.

Enrollment plan was as follows: The first 10 were enrolled in Arm A, the next 10 were enrolled in Arm B and the last 10 were to be enrolled in Arm C. 10 participants were enrolled on Arm A, 8 participants on Arm B and 0 on Arm C. Of the 8 participants in Arm B, only 6 were analyzed because 2 withdrew before receiving bortezomib.

Participant milestones

Participant milestones
Measure	Bortezomib, Cohort a treatment: 1.3 mg/m\^2	Bortezomib, Cohort b treatment: 1.0 mg/m\^2
Overall Study STARTED	10	8
Overall Study Received Bortezomib	10	6
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bortezomib, Cohort a n=10 Participants treatment: 1.3 mg/m\^2	Bortezomib, Cohort b n=8 Participants treatment: 1.0 mg/m\^2	Bortezomib, Cohort c treatment: 0.7 mg/m\^2	Total n=18 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	—	0 participants n=4 Participants
Age Categorical Between 18 and 65 years	6 participants n=5 Participants	3 participants n=7 Participants	—	9 participants n=4 Participants
Age Categorical >=65 years	4 participants n=5 Participants	5 participants n=7 Participants	—	9 participants n=4 Participants
Age Continuous	65 years STANDARD_DEVIATION 8.78 • n=5 Participants	70.75 years STANDARD_DEVIATION 8.69 • n=7 Participants	—	67.55 years STANDARD_DEVIATION 8.98 • n=4 Participants
Gender Female	5 participants n=5 Participants	4 participants n=7 Participants	—	9 participants n=4 Participants
Gender Male	5 participants n=5 Participants	4 participants n=7 Participants	—	9 participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	8 participants n=7 Participants	—	18 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Parathyroid hormone: Any increase in PTH was considered response

Outcome measures

Outcome measures
Measure	Cohort A n=10 Participants Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)	Cohort B n=6 Participants Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone	4 participants	3 participants

PRIMARY outcome

Timeframe: 6 months

Calcium: any Calcium increase would refer to a positive response.

Outcome measures

Outcome measures
Measure	Cohort A n=10 Participants Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)	Cohort B n=6 Participants Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium	0 participants	0 participants

PRIMARY outcome

Timeframe: 6 months

Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response

Outcome measures

Outcome measures
Measure	Cohort A n=10 Participants Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)	Cohort B n=6 Participants Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase	4 participants Interval 4.5 to 48.4	3 participants

PRIMARY outcome

Timeframe: 6 months

Magnesium: Any Magnesium increase would refer to a positive response.

Outcome measures

Outcome measures
Measure	Cohort A n=10 Participants Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)	Cohort B n=6 Participants Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium	0 participants	0 participants

PRIMARY outcome

Timeframe: 6 months

Phosphate: any Phosphate increase would refer to a positive response.

Outcome measures

Outcome measures
Measure	Cohort A n=10 Participants Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)	Cohort B n=6 Participants Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 months

Osteocalcin: Any Osteocalcin increase means positive response.

Outcome measures

Outcome measures
Measure	Cohort A n=10 Participants Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)	Cohort B n=6 Participants Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin	4 participants	3 participants

Adverse Events

Bortezomib, Cohort a

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bortezomib, Cohort b

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Bortezomib, Cohort c

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bortezomib, Cohort a n=10 participants at risk treatment: 1.3 mg/m\^2	Bortezomib, Cohort b n=6 participants at risk treatment: 1.0 mg/m\^2	Bortezomib, Cohort c treatment: 0.7 mg/m\^2
General disorders unsteady gait and mental status changes	0.00% 0/10 • The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007 Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step	16.7% 1/6 • Number of events 1 • The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007 Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step	— 0/0 • The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007 Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step

Other adverse events

Adverse event data not reported

Additional Information

Nathan M. Petty

University of Arkansas for Medical Sciences, Myeloma Institute

Phone: 501-526-6990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place