Clinical trial · Interventional
Modified Bortezomib-based Combination Therapy for Multiple Myeloma
An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma
NCT02559154CI-TRIAL-00032776unknownPhase 4ClinicalTrials.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)
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Mitoxsnteone | Drug | — | UNRESOLVED |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- modified BZ group
- description
- Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide
- interventionNames
- Drug: Bortezomib
- Drug: Dexamethasone
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Mitoxsnteone
- Drug: Thalidomide
- type
- ACTIVE_COMPARATOR
- label
- conventional BZ group
- description
- Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma based on standard diagnosis criteria: * plasmacytomas on tissue biopsy * bone marrow plasmacytosis * monoclonal immunoglobulin spike on serum electrophoresis * lytic bone lesions. * Must have relapsed or relapsed/refractory disease * 18 years of age or older * All baseline studies must be performed within 21 days of enrollment. * ECOG performance status of 0 to 2 Exclusion Criteria: * Renal insufficiency (serum creatinine levels \> 2mg/dL) * Concomitant therapy medications that include corticosteroids * Peripheral neuropathy of Grade 3 or greater or painful Grade 2 * Evidence of mucosal or internal bleeding and/or platelet refractory * ANC \< 1000 cells/mm3 * Hemoglobin \< 8.0 g/dL * AST (SGOT and ALT) \> 2 x ULN * Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol * Known hypersensitivity to thalidomide or the development of erythema nodosum * Active infection or serious co-morbid medical condition * Pregnant or breast-feeding women * Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
References
Publications (0)
Data not yet available
No reference posted for this study.