Clinical trial · Interventional
Preemptive Strike With Bortezomib in Multiple Myeloma Patients
Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)
NCT00657553CI-TRIAL-000304342007-77terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual
Summary
Brief summary (as posted)
To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.
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 (2)
- type
- ACTIVE_COMPARATOR
- label
- Bortezomib/Treatment Arm
- description
- Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months
- interventionNames
- Drug: Bortezomib
- type
- NO_INTERVENTION
- label
- Observation Arm (watchful waiting)
- description
- monitor myeloma parameters every 3-6 months
Primary outcomes (1)
- measure
- Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2
- timeFrame
- three years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and currently event-free at the time of the evaluation. * Performance status of 0-2 based of Southwest Oncology Group (SWOG) criteria * Previously documented platelet count \> 75,000/ul within a 35 days prior to enrollment * Previously documented peripheral absolute neutrophil count \>1,000/ul within 35 days prior to enrollment. * Adequate renal function * Signed informed consent * Female subject is post-menopausal or willing to use acceptable birth control * Male subjects agree to use acceptable method of contraceptive Exclusion Criteria: * Hypersensitivity to Bortezomib, boron, or mannitol * Female subject is pregnant or breastfeeding * Experienced myocardial infraction within 6 months prior to enrollment * Received other investigational new drugs within 14 days before enrollment * Received any anti-myeloma therapy within 14 days * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Diagnosed or treated for another malignancy within 3 years of enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.