drugset / Trial / NCT01146834

Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma

NCT01146834 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy or other therapies. Up to 180 patients will be enrolled. Patients eligible for treatment will be randomized to one of the three following mobilization regimens: Arm A = VELCADE, CYCLOPHOSPHAMIDE, \& G-CSF Arm B = VELCADE \& G-CSF Arm C = CYCLOPHOSPHAMIDE \& G-CSF Arm D = PLERIXAFOR \& G-CSF Arm E = PLERIXAFOR, VELCADE, \& G-CSF

Timeline

Start
2011-03
Primary completion
2019-02-04
Completion
2019-02-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF vs Arm C: CYCLOPHOSPHAMIDE & G-CSF; p = 0.90 NCT01146834 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 2 g —
Subject Plerixafor Small molecule — —
Background filgrastim Protein / enzyme biologic 10 ug/kg —

Indications