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UARK 2005-01 Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients

NCT00111748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-10-06

No results posted yet for this study

Summary

The main goal of this study is to evaluate the effectiveness of the combination of these drugs, and whether they can be given safely together.

Conditions

Interventions

DRUG

Velcade, Thalidomide, Dexamethasone

Dosage and Administration Schedule Each cycle will consist of 3 weeks (21 days). AGENT DOSE ROUTE DAYS Velcade 1.0 mg/m2 IV 1, 4, 8, and 11 Thalidomide 100 mg PO Daily, hs Dexamethasone 20 mg PO Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg SQ Days 1-14 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). The next cycle of treatment may be delayed up to day 29 due to non-toxicity reasons. Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a maximum of eight cycles. At the discretion of the treating physician, patients may be eligible to receive treatment at their local physician after completion of the 1st cycle. These patients will need to return to MIRT prior to every cycle for cycles 2-4, cycles 6 and 8, and final visit.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Klaus Hollmig, MD · University of Arkansas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00111748 on ClinicalTrials.gov