Clinical trial · Observational
Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.
Observational Study of Osteoblast Activity in Velcade�(Bortezomib) IV Treated Multiple Myeloma Patients.
NCT01026701CI-TRIAL-00014352completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 001
- description
- bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC)
- timeFrame
- on day 1 at the first cycle, and 12-24 weeks
Secondary outcomes (5)
- measure
- CR rate
- timeFrame
- at the end of every 3 week cycle
- measure
- Overall response rate
- timeFrame
- at the end of every 3 week cyclet
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included. Exclusion Criteria: * Patients who are hypersensitive to the study drug or any component of the study drug or with a history of the hypersensitivity * Patients with severe hepatic impairment * Women who are pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.