Chemotherapy Regimen for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byMaurizio Zangari, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy. Past studies conducted at the MIRT have shown that participants presenting to MIRT who have already received treatment for myeloma tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants who come to MIRT with untreated myeloma. Researchers at MIRT think that one reason for this is may be that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.

Research Team

Maurizio Zangari, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 75 years old.

I have never had a bone marrow or stem cell transplant.

Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study

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Exclusion Criteria

Platelet count < 30,000/mm3, and ANC < 1,000/μl

I have POEMS Syndrome.

I have severe heart failure.

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Treatment Details

Interventions

Adriamycin (Anti-tumor antibiotic)
Cisplatin (Alkylating agents)
Cyclophosphamide (Alkylating agents)
Dexamethasone (Corticosteroid)
Etoposide (Topoisomerase Inhibitor)
Melphalan (Alkylating agents)
Thalidomide (Immunomodulatory Agent)
Velcade (Proteasome Inhibitor)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MEL-VTD-PACEExperimental Treatment8 Interventions

Melphalan, Velcade, Thalidomide, Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, Etoposide