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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
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 belowSelect...
I am younger than 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My diabetes is not under control.
Select...
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.
Select...
I do not have light chain deposition disease and my creatinine is below 3 mg/dl.
Select...
I do not have severe numbness or pain in my hands or feet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
Adriamycin
2015
Completed Phase 4
~5930
Dexamethasone
2007
Completed Phase 4
~2640
Cisplatin
2013
Completed Phase 3
~2360
Thalidomide
2001
Completed Phase 4
~3050
Cyclophosphamide
2010
Completed Phase 4
~2320
Etoposide
2010
Completed Phase 3
~2960
Velcade
2006
Completed Phase 4
~1750
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
493 Previous Clinical Trials
150,786 Total Patients Enrolled
54 Trials studying Multiple Myeloma
11,803 Patients Enrolled for Multiple Myeloma
Gareth Morgan, MD, PhDPrincipal InvestigatorUAMS Myeloma Institute for Research and Therapy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to bortezomib, boron, or mannitol.Your platelet count is less than 30 x 10^9/L, unless it is related to myeloma.My diabetes is not under control.I am younger than 75 years old.I haven't had recent heart issues like a heart attack or unstable blood pressure.I haven't had cancer before, except for certain skin cancers or cervical cancer that's been treated.My blood or urine tests show abnormal protein levels, or I have significant bone marrow cancer cells.I have a long-term lung condition that affects my breathing.I am not pregnant or nursing, have a recent negative pregnancy test, and agree to use contraception.I do not have major health issues or uncontrolled serious infections.My lung function tests are above 50% of what's expected, or I have an exception due to my condition.I can take care of myself but may not be able to do heavy physical work. If I have severe bone pain, I might still qualify.Your heart's pumping ability, measured by a test like ECHO or MUGA, is at least 40%.I've had only one round of chemotherapy for my condition and possibly radiotherapy with approval.I do not have light chain deposition disease and my creatinine is below 3 mg/dl.I have newly diagnosed active multiple myeloma needing treatment, or my smoldering myeloma has progressed and now requires chemotherapy.I do not have severe numbness or pain in my hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: VDTPACE
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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