At a glance
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An Open Label, Single-Arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment With Lenalidomide, Bortezomib, Dexamethasone and Siltuximab (CNTO 328) in Subjects With Newly Diagnosed, Previously Untreated Multiple Myeloma Requiring Systemic Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Lenalidomide, Bortezomib, and 3 other interventions for Myeloma. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to find the highest tolerable dose of Siltuximab that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone to patients with MM. The safety of this drug combination will also be studied.
Study Details
Timeline
Interventions
Induction Phase: 25 mg by mouth daily on Days 1-14. Maintenance Phase: at last tolerated dose from Induction Phase day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg.
Induction Phase: 1.3 mg/m2 by vein daily on Days 1, 4, 8 and 11. Maintenance Phase: 1.3 mg/m2 by vein or last tolerated dose on Day 1 and Day 8.
Induction Phase Starting Dose: 11 mg/kg by vein on Day 1. Maintenance Phase: 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy.
Induction Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12. Maintenance Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12. If participant still on Dexamethasone, when entering Maintenance Phase, dose reduced to 20 mg a week.
M. D. Anderson Symptom Inventory Module (MDASI-MM) completed Day 1, Day 8 of Cycle 1 - 8, and on Day 1 of Cycle 9 and beyond.