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UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission
Sponsor: University of Arkansas
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
Conditions
Interventions
Velcade
1.0mg/m2 days 1, 5, 8, \& 11
Melphalan
10 mg/m2 day 3
Thalidomide
200 mg days 5-8
Dexamethasone
40 mg day 5-8
Cisplatin
10 mg/m2 day 5-8
Adriamycin
10 mg/m2 day 5-8
Cyclophosphamide
400 mg/m2 day 5-8
Etoposide
40 mg/m2 day 5-8
Locations (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States