drugset / Trial / NCT00871013

Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy

NCT00871013 ↗

Phase 2 Active not recruiting 160 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 have shown that participants presenting to MIRT who have already received treatment for myeloma tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants who come to MIRT with untreated myeloma. Researchers at MIRT think that one reason for this is may be 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
2009-03
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule — Intravenous
Subject Cisplatin Other / unclassified — Intravenous
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Dexamethasone Small molecule — Oral
Subject Doxorubicin Other / unclassified — Intravenous
Subject Etoposide Small molecule — Intravenous
Subject Melphalan Small molecule — Intravenous
Subject Thalidomide Other / unclassified — Oral

Indications