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Anti-tumor antibiotic

Chemotherapy Regimen for Multiple Myeloma

Phase 2
Waitlist Available
Led By Maurizio Zangari, MD
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 at least 18 years of age and not older than 75 years of age at the time of registration
Patient must not have had a prior auto- or allotransplant
Must not have
New York Heart Association (NYHA) Class III or Class IV heart failure
Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance of < 30ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new chemotherapy regimen for myeloma patients who have already had treatment. Results from past studies conducted at MIRT show that patients treated with this new regimen have longer remissions and better responses to treatment than patients who received standard chemotherapy.

Who is the study for?
This trial is for adults aged 18-75 with symptomatic multiple myeloma, who have had prior chemotherapy or are newly diagnosed. They must have good heart and lung function, no severe past reactions to certain drugs like thalidomide or bortezomib, and no other serious illnesses that could affect the study. Pregnant women can't join, and participants must agree to use contraception.
What is being tested?
The trial tests a combination of chemotherapy drugs (Adriamycin, Etoposide, Cisplatin, Cyclophosphamide, Dexamethasone, Melphalan, Velcade & Thalidomide) in lower doses but more frequent cycles. The aim is to prevent myeloma cells from regrowing between treatments to achieve longer remission periods.
What are the potential side effects?
Potential side effects include nausea and vomiting from Adriamycin; low blood counts from Etoposide; kidney damage from Cisplatin; hair loss and bladder issues from Cyclophosphamide; weight gain from Dexamethasone; mouth sores from Melphalan; nerve damage from Velcade; and drowsiness or constipation from Thalidomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have never had a bone marrow or stem cell transplant.
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My lung function tests are at least half of what's expected, or I've had a CT scan due to chest pain from myeloma.
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I have multiple myeloma and have had at least one chemotherapy treatment or none if newly diagnosed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart failure.
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My kidney function is severely impaired.
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I have not had a recent heart attack or uncontrolled heart problems in the last 6 months.
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I have received more than 450 mg/m2 of Adriamycin in total.
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I had a severe reaction to thalidomide and had to stop taking it.
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I have been treated for serious heart rhythm problems.
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I had a severe reaction to Revlimid and had to stop taking it.
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I am allergic to boron, Mannitol, or had a severe reaction to bortezomib.
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My liver is not functioning well, shown by high bilirubin or AST levels.
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I do not have severe nerve damage symptoms.

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

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MEL-VTD-PACEExperimental Treatment8 Interventions
Melphalan, Velcade, Thalidomide, Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, Etoposide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Thalidomide
2001
Completed Phase 4
~3050
Cyclophosphamide
2010
Completed Phase 4
~2310
Etoposide
2010
Completed Phase 3
~2960
Melphalan
2008
Completed Phase 3
~1500
Velcade
2006
Completed Phase 4
~2460
Dexamethasone
2007
Completed Phase 4
~2650
Adriamycin
2015
Completed Phase 4
~5930

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,170 Total Patients Enrolled
56 Trials studying Multiple Myeloma
11,998 Patients Enrolled for Multiple Myeloma
Maurizio Zangari, MDPrincipal InvestigatorUniversity of Arkansas
6 Previous Clinical Trials
454 Total Patients Enrolled
6 Trials studying Multiple Myeloma
454 Patients Enrolled for Multiple Myeloma

Media Library

Adriamycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00871013 — Phase 2
Multiple Myeloma Research Study Groups: MEL-VTD-PACE
Multiple Myeloma Clinical Trial 2023: Adriamycin Highlights & Side Effects. Trial Name: NCT00871013 — Phase 2
Adriamycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00871013 — Phase 2
~10 spots leftby Dec 2025
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