drugset / Trial / NCT00570180
Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma
Phase 2
Completed
36 enrolled
University Health Network, Toronto
Ortho Biotech, Inc. · collabPrincess Margaret Hospital, Canada · collab
NaSingle-groupOpen-labelTreatment
Summary
Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open label phase II study of bortezomib along with dexamethasone and pegylated liposomal doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse, maintenance therapy with dexamethasone weekly will be given until disease progression.
Timeline
- Start
- 2008-08-25
- Primary completion
- 2015-09-15
- Completion
- 2015-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.5 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 100 mg | Oral |