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

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.

Conditions

• Myeloma

Interventions

DRUG

Melphalan

Given by vein, Day 3 First Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4 Second Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4 Second Transplant Bortezomib (Velcade) By vein Day -5 and Day -2 Year 1 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 28 days Years 2 \& 3 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 56 days

DRUG

Velcade

Given by vein, Days 1, 5, 8, 11

DRUG

Thalidomide

Given by mouth at bedtime, Days 5-8

DRUG

Dexamethasone

Given by mouth, once per day Days 5-8

DRUG

Cisplatin

Given by vein, Days 5-8 continuous infusion

DRUG

Adriamycin

Given by vein, days 5-8 continuous infusion

DRUG

Cyclophosphamide

Given by vein days 5-8 continuous infusion

DRUG

Etoposide

Given by vein days 5-8 continuous infusion

Sponsors & Collaborators

• University of Arkansas

  lead OTHER

Principal Investigators

• Maurizio Zangari, MD · University of Arkansas

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United States

Study Locations