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UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission

NCT00869232 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-22

No results posted yet for this study

Summary

There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy.

Past studies conducted at the MIRT and at other institutions have shown that participants with high-risk features by gene array studies tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. Researchers at MIRT think that one reason for this is that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.

Conditions

Interventions

DRUG

Etoposide

40 mg/m2 day 5-8

DRUG

Velcade

1.0mg/m2 days 1, 5, 8, \& 11

DRUG

Melphalan

10 mg/m2 day 3

DRUG

Thalidomide

200 mg days 5-8

DRUG

Dexamethasone

40 mg day 5-8

DRUG

Cisplatin

10 mg/m2 day 5-8

DRUG

Adriamycin

10 mg/m2 day 5-8

DRUG

Cyclophosphamide

400 mg/m2 day 5-8

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Frits van Rhee, MD, PhD · UAMS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2027-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States

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 NCT00869232 on ClinicalTrials.gov