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DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation

NCT00083915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2017-11-20

Study results available
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Summary

The purpose of this study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. DT-PACE refers to a chemotherapy regimen for multiple myeloma consisting of Dexamethasone, Thalidomide, Cisplatin or Platinol, Adriamycin or doxorubicin, Cyclophosphamide, and Etoposide. Another purpose of this study is to find out if there will be fewer side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone.

Conditions

Interventions

DRUG

Cisplatin

20mg/m2 continuous infusion days -3 and -2.

DRUG

Cyclophosphamide

800 mg/m2 continuous infusion days -3 and -2.

DRUG

Adriamycin

20mg/m2 continuous infusion -3 and -2.

DRUG

Etoposide

80mg/m2 continuous infusion -3 and -2.

DRUG

Melphalan

200 mg/m2 IV over \<20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.

DRUG

Thalidomide

200mg PO Continuing to Day +5, then hold until platelets \>50 thousand (K).

DRUG

Dexamethasone

40 mg po days 1 - 4 (4 days)

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Frits van Rhee, M.D., Ph.D. · UAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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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 NCT00083915 on ClinicalTrials.gov