Clinical trial · Interventional
Bortezomib Consolidation Trial
Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma
NCT01517724CI-TRIAL-00038204BCTcompletedPhase 2ClinicalTrials.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 aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health.
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)
- type
- EXPERIMENTAL
- label
- Bortezomib consolidation
- description
- Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)
- interventionNames
- Drug: Bortezomib
Primary outcomes (2)
- measure
- Change in Disease response
- timeFrame
- At 6 and 12 months after ASCT consolidated by bortezomib therapy
- description
- Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.
- measure
- Number of patients with adverse events
- timeFrame
- Up to 8 months after treatment start
- description
- The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * MM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed * Age 18 - 70 years * Life expectancy \> 6 months * Written informed consent * Creatinine \< 400µmol/L * Bilirubin \< 3x upper limit of normal * WHO performance status 0-2 * Contraceptive precautions where appropriate Exclusion Criteria: * Received bortezomib previously * On, or planned for, steroid therapy * Poor performance status (ECOG ≥ 3) * Disease progression at any stage * Past history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2 * Severe hepatic impairment, indicated by bilirubin ≥ 3x upper limit of normal, or AST \> 2.5x upper limit of normal * Pregnant or lactating women * Allergic reaction attributable to bortezomib or to compounds containing boron or mannitol * Severe cardiovascular disease * History of acute infiltrative pulmonary or pericardial disease * History of hypotension or has decreased blood pressure * Peripheral neuropathy ≥ grade 2, or neuropathic pain * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Received any drugs or agents that inhibit or induce CYP2C19 or CYP3A4 within 14 days before the first dose of bortezomib * Need for therapy with concomitant CYP 3A4 or CYP2C19 inhibitors * Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
References
Publications (0)
Data not yet available
No reference posted for this study.