drugset / Trial / NCT00869232

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

NCT00869232 ↗

Phase 2 Active not recruiting 90 enrolled University of Arkansas
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-10
Primary completion
2027-10
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2 —
Subject Cisplatin Other / unclassified 10 mg/m2 —
Subject Cyclophosphamide Other / unclassified 400 mg/m2 —
Subject Dexamethasone Small molecule 40 mg —
Subject Doxorubicin Other / unclassified 10 mg/m2 —
Subject Etoposide Small molecule 40 mg/m2 —
Subject Melphalan Small molecule 10 mg/m2 —
Subject Thalidomide Other / unclassified 200 mg —

Indications