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ACTIVE NOT RECRUITING
NCT00869232
PHASE2

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

Sponsor: University of Arkansas

View on ClinicalTrials.gov

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.

Official title: UARK 2008-02, A Phase II Trial for High-risk Myeloma Evaluation Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-host-exhausting and Timely Dose-reduced MEL-80-VRD-PACE Tandem Transplants

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2008-10

Completion Date

2027-10

Last Updated

2025-06-29

Healthy Volunteers

No

Interventions

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

DRUG

Etoposide

40 mg/m2 day 5-8

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States