MedTrace Logo

Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD

NCT00908232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2015-01-15

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells.

Conditions

Interventions

DRUG

Cyclophosphamide

500 mg, p.o daily, days 1, 8 and 15 for cycles 5 to 8 cycles

DRUG

Bortezomib

1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 for cycles 1 to 8

DRUG

Dexamethasone

20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycles 1 to 8

DRUG

Lenalidomide

10 mg orally daily, days 1-14 for cycles 5 to 8

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • France
  • Germany
  • Greece
  • Hungary
  • Lithuania
  • Poland
  • Serbia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00908232 on ClinicalTrials.gov