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Anti-tumor antibiotic
Chemotherapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Frits van Rhee, 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 either untreated or have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.
Patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 60 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing a new lower-dose, shorter-cycle chemotherapy regimen to see if it can help people with high-risk myeloma achieve longer remissions and improved survival.
Who is the study for?
This trial is for adults aged 18-75 with newly diagnosed active multiple myeloma that requires treatment. Participants should have high-risk disease characteristics, adequate kidney function (serum creatinine level < 3 mg/dL), and good heart and lung function. They must not have received more than one cycle of systemic therapy, excluding certain treatments like bisphosphonates.
What is being tested?
The study tests a combination of chemotherapy drugs (Cyclophosphamide, Velcade, Dexamethasone, Cisplatin, Thalidomide, Etoposide, Melphalan, Adriamycin) given in lower doses but more frequently to prevent myeloma cells from regrowing between cycles. The goal is to achieve longer remissions and improve survival time for those with high-risk myeloma.
What are the potential side effects?
Potential side effects include nausea and vomiting from the chemotherapy drugs; numbness or tingling due to Thalidomide; increased risk of infection; blood clots; fatigue; hair loss; low blood cell counts leading to bleeding or bruising easily.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had no or just one round of treatment for my multiple myeloma, not counting bone treatments or spot radiation.
Select...
I am between 18 and 75 years old.
Select...
My kidney function is good, with a creatinine level below 3 mg/dL.
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
Awards & Highlights
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MEL--VTD-PACEExperimental Treatment8 Interventions
Melphalan, Velcade, Thalidomide, Dexamethasone, Cisplatin, Adriamycin, Cyclophosphamide and Etoposide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib D-mannitol
FDA approved
Dexamethasone
FDA approved
Cisplatin
FDA approved
Cyclophosphamide
FDA approved
Thalidomide
FDA approved
Etoposide
FDA approved
Melphalan
FDA approved
Doxorubicin
FDA approved
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,240 Total Patients Enrolled
56 Trials studying Multiple Myeloma
12,068 Patients Enrolled for Multiple Myeloma
Frits van Rhee, MD, PhDPrincipal InvestigatorUAMS
5 Previous Clinical Trials
38 Total Patients Enrolled
5 Trials studying Multiple Myeloma
38 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer before, except for certain skin cancers or cervical cancer that's been treated.I have had no or just one round of treatment for my multiple myeloma, not counting bone treatments or spot radiation.My lung function tests are at least half of what is expected, or I have an exception due to my condition.I am between 18 and 75 years old.You need to have a certain level of heart function, as measured by a heart imaging test.My condition is not considered high-risk.My kidney function is good, with a creatinine level below 3 mg/dL.You have a high-risk form of the disease, as determined by specific test results or symptoms.My health conditions are well-managed and won't affect my treatment.Your platelet count should be at least 50,000 per microliter of blood, unless your doctor can explain that lower levels are caused by a specific condition in your bone marrow.I have newly diagnosed active multiple myeloma needing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: MEL--VTD-PACE
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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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