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Anti-tumor antibiotic

Combination Chemotherapy for Multiple Myeloma

Phase 3
Waitlist Available
Led By Gareth Morgan, MD, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be <75 years of age at the time of initial registration.
Be older than 18 years old
Must not have
Uncontrolled diabetes.
Recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is continuing the research from Total Therapy I and II to explore why chromosome abnormalities found in persons with multiple myeloma affect the outcome of drug therapy used in this disease.

Who is the study for?
This trial is for patients under 75 with newly diagnosed active Multiple Myeloma needing treatment. They can have had one cycle of chemotherapy, must be able to perform daily activities (performance status 0-2), and have decent heart and lung function. Pregnant women or those with serious health issues, recent heart problems, uncontrolled diabetes, severe lung disease, or a history of other cancers are excluded.
What is being tested?
Total Therapy IIIB aims to improve outcomes in Multiple Myeloma by testing a combination of drugs: Cisplatin, Thalidomide, Dexamethasone, Adriamycin (Doxorubicin), Cyclophosphamide, Etoposide and Velcade (Bortezomib). It builds on previous Total Therapy studies to understand how chromosome abnormalities affect drug response.
What are the potential side effects?
Potential side effects include nausea from Cisplatin; drowsiness or nerve damage from Thalidomide; weight gain from Dexamethasone; heart damage from Adriamycin; hair loss from Cyclophosphamide; mouth sores from Etoposide; and nerve pain or fatigue from Velcade.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am younger than 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes is not under control.
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I haven't had recent heart issues like a heart attack or unstable blood pressure.
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I have a long-term lung condition that affects my breathing.
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I do not have light chain deposition disease and my creatinine is below 3 mg/dl.
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I do not have severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VDTPACEExperimental Treatment7 Interventions
Velcade, Dexamethasone, Thalidomide, Cisplatinin, Adriamycin, Cyclophosphamide and Etoposide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Adriamycin
2015
Completed Phase 4
~5930
Cisplatin
2013
Completed Phase 3
~3120
Thalidomide
2001
Completed Phase 4
~3050
Cyclophosphamide
2010
Completed Phase 4
~2310
Etoposide
2010
Completed Phase 3
~2960
Velcade
2006
Completed Phase 4
~2460

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,153 Total Patients Enrolled
56 Trials studying Multiple Myeloma
11,981 Patients Enrolled for Multiple Myeloma
Gareth Morgan, MD, PhDPrincipal InvestigatorUAMS Myeloma Institute for Research and Therapy

Media Library

Adriamycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00572169 — Phase 3
Multiple Myeloma Research Study Groups: VDTPACE
Multiple Myeloma Clinical Trial 2023: Adriamycin Highlights & Side Effects. Trial Name: NCT00572169 — Phase 3
Adriamycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00572169 — Phase 3
~6 spots leftby Aug 2025