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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 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accelerate and sustain, at 2 years from starting therapy
Secondary outcome measures
48hrs after melphalan 10mg/m2, gene expression profiling (GEP) examinations of CD138-purified MM plasma cells (PC)and of bone marrow biopsy (BX)samples

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
486 Previous Clinical Trials
150,263 Total Patients Enrolled
54 Trials studying Multiple Myeloma
11,890 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

Adriamycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00869232 — Phase 2
Multiple Myeloma Research Study Groups: MEL--VTD-PACE
Multiple Myeloma Clinical Trial 2023: Adriamycin Highlights & Side Effects. Trial Name: NCT00869232 — Phase 2
Adriamycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00869232 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please summarize the risks associated with Cisplatin?

"Cisplatin is a Phase 2 medication, which suggests that while there is some evidence of safety, there is none for efficacy."

Answered by AI

Does this research involve elderly individuals?

"According to the screening process for this clinical trial, the age range of patients that can be enrolled starts at 18 and ends when the patient turns 75."

Answered by AI

Does this research break new ground in the medical field?

"There are currently 2286 active clinical trials for Cisplatin around the world. The first trial was conducted in 1997 and involved 300 participants. 3741 trials have been completed since then."

Answered by AI

How many study subjects are you working with currently?

"Unfortunately, this study has already wrapped up recruitment. The trial was initially posted on October 1st, 2008 and was last updated September 2nd, 2022. However, there are 827 other trials for patients with multiple myeloma and 2286 clinical trials involving Cisplatin that are actively recruiting participants."

Answered by AI

Can new patients enroll in this clinical trial at this time?

"Unfortunately, this trial is no longer recruiting patients. The listing was created on October 1st, 2008 and last updated September 2nd, 2022. There are 827 other trials for multiple myeloma and 2286 Cisplatin clinical trials that are currently looking for participants."

Answered by AI

Who meets the requirements to participate in this research project?

"This clinical trial is looking for 90 participants that have a multiple myeloma diagnosis and are between 18-75 years old. To be eligible, patients must: have newly diagnosed active MM that requires treatment, cannot have had more than one cycle of systemic MM therapy (excluding bisphosphonates and localized radiation), GEP risk score must be > or = 0.66 or LDH must be > or = 360 U/L, Zubrod < or = 2, platelet count must be > or = 50,000/uL, ejection fraction by ECHO or MUGA scan > or = 45%, adequate pulmonary"

Answered by AI

Under what conditions is Cisplatin usually given to patients?

"Cisplatin is used to fight Kaposi's sarcoma, which is often related to AIDS. It can also be employed against other conditions such as leukemia, synovitis, and Merkel cell cancer."

Answered by AI
~2 spots leftby Oct 2024