Trial Outcomes & Findings for Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates (NCT NCT00577642)

Last Updated: 2017-03-10

Results Overview

Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

6 months

Results posted on

2017-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Zoledronic Acid Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.
Overall Study STARTED	29
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Zoledronic Acid Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.
Overall Study Clinical Disease Progression	1

Baseline Characteristics

Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoledronic Acid n=29 Participants Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants
Age, Categorical >=65 years	10 Participants n=93 Participants
Age, Continuous	60 years n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Region of Enrollment United States	29 participants n=93 Participants
ISS Stage Stage I	11 participants n=93 Participants
ISS Stage Stage II	9 participants n=93 Participants
ISS Stage Stage III	9 participants n=93 Participants
Therapy Bortezomib + lenalidomide	14 participants n=93 Participants
Therapy Bortezomib + Other	10 participants n=93 Participants
Therapy Other	5 participants n=93 Participants
Autologous Transplant Yes	13 Participants n=93 Participants
Autologous Transplant No	16 Participants n=93 Participants
Bone Lesions > 3 bone lesions	20 participants n=93 Participants
Bone Lesions ≤ 3 bone lesions	9 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=29 Participants Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) treatment cessation during study period.
Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr NTX level ≤ 50 nmol/mmol Cr	28 Participants
Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr NTX level > 50 nmol/mmol Cr	1 Participants

Adverse Events

Single Arm Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Noopur Raje

Massachusetts General Hospital

Phone: 6177260711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place