CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 47 enrolled
Drug / intervention
bortezomib (Velcade) +3 moredrug
Likely dose
bortezomib (Velcade) 1.3 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01146834
NCT01146834Phase 3Completed
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A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma or Lymphoma

Weill Medical College of Cornell University·interventional·Posted Jun 22, 2010·Updated Dec 27, 2019

In Brief

A Phase 3 clinical trial evaluating bortezomib (Velcade), cyclophosphamide, and 2 other interventions for Multiple Myeloma. Completed, enrolled 47 participants across 5 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartMar 1, 2011
Primary CompletionFeb 4, 2019
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 16.0 years ago

Interventions

bortezomib (Velcade)drug

1.3 mg/m2 IVP on days 1, 4, 8 and 11

cyclophosphamidedrug

2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)

G-CSFdrug

given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)

Plerixafordrug

plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)