At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of multiple myeloma by SWOG criteria
- ✓Age ≥18 years
- ✓Karnofsky performance status ≥70% (≥60% if due to bony myeloma involvement)
- ✓Measurable disease: post-induction patients require any paraprotein/plasmacytoma; relapsed/refractory patients require >0.5 g/dL serum M-protein, >0.1 g/dL free light chains, >0.2 g/24 hrs urine M-protein, or measurable plasmacytoma
- ✕Non-secretory MM without measurable disease on imaging (MRI/PET)
- ✕Prior bortezomib treatment
- ✕Peripheral neuropathy >Grade 2 (CTCAE v3.0)
- ✕Allergy to mannitol, bortezomib, conventional doxorubicin HCL, or DOXIL components
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients
In Brief
A Phase 2 clinical trial evaluating Bortezomib, dexamethasone, and 3 other interventions for Multiple Myeloma. Completed, enrolled 38 participants across 1 site.
Detailed Summary
PRIMARY STUDY OBJECTIVES * To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients: 1. Patients post first line therapy 2. Patients with relapsed/refractory disease who are bortezomib-naïve * To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma. SECONDARY STUDY OBJECTIVES * To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect \> 10 x 106 CD34+ cells/kg in \< 7 collections (for both subsets of multiple myeloma patients). * To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).
Study Details
Timeline
Interventions
During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11
During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18
If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cycles
During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8
During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9