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UARK 2003-41: A Study of High-Dose Density Therapy in Patients With Multiple Myeloma

NCT00113932 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2011-09-02

No results posted yet for this study

Summary

The purpose of this study is to find out if treating multiple myeloma (MM) patients with more intense chemotherapy and autologous transplant (high dose density therapy) early in the disease course will result in better treatment outcomes compared to patients treated in the past.

Conditions

Interventions

PROCEDURE

High-Dose Density Therapy

Dexamethasone 40mg po 1-4, Thalidomide 200 mg po 1-6hrs then daily after transplant; Cisplatin\* 10 mg/m2 Continuous infusion 1-4;Adriamycin 10 mg/m2 Continuous infusion 1-4;Cyclophosphamide 400 mg/m2 Continuous infusion 1-4; Etoposide 40 mg/m2 Continuous infusion 1-4; Pegfilgrastim 6 mg subcutaneously 6 and 13; Darbepoetin 200μg subcutaneously Between -6 to-1 +12, \& every 2 weeks until HB \>12 gm/dl\*\*\*; Lovenox (or other LMWH) 40 mg subcutaneously Daily until Pltcount \<30,000/μl

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Frits Van Rhee, MD, PhD · UAMS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2009-02-28
Completion
2010-07-31

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 NCT00113932 on ClinicalTrials.gov