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UARK 89-001 Phase II Study of Intensive "TOTAL THERAPY" For Untreated or Minimally Treated Patients With Multiple Myeloma

NCT00580372 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2016-09-20

Study results available
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Summary

This experimental study evaluates the effects of a series of intensive drug regimens as initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4-6 months apart in support of high-dose Melphalan, followed by Interferon treatment indefinitely.

Conditions

Interventions

DRUG

VAD

3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20

DRUG

High-Dose cyclophosphamide

Approximately 5-6 weeks after VAD 2 or 3: Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1

PROCEDURE

Hemopoietic stem cell procurement

Collection target = 10 x 10\^6 cells/kg

DRUG

EDAP

Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5

PROCEDURE

Autologous Hemopoietic Stem Cell Transplant 1

4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2

PROCEDURE

Autologous Hemopoietic Stem Cell Transplant 2

4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2

DRUG

Maintenance

3 months after Transplant 2: Intron A 3 X 10\^6 units /m2 M-W-F subcutaneously until relapse

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Bart Barlogie, MD, PhD · University of Arkansas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2015-10-31
Completion
2015-10-31

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 NCT00580372 on ClinicalTrials.gov