NCT00869232

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* To find out if giving multi-agent chemotherapy in lower and more frequent doses to make the timely delivery of chemotherapy cycles possible, will result in better treatment outcomes * To find out if changing the way the drugs are given during the transplant phase will also result in fewer side effects, while still being effective * To find out if giving treatment between transplants (called "inter-transplant therapy") will prevent the myeloma from re-growing between transplants * To find out if long-term maintenance therapy will result in longer remissions * To find out what the effects (good and bad) of this overall treatment will be * To learn more about the biology and genetics of multiple myeloma by performing imaging tests and collecting blood, bone marrow aspirate and biopsies, and biopsies of lesions seen on MRI or PET scans for research

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-10-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2009-03-25
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study