Chemotherapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byFrits van Rhee, MD, PhD

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 and at other institutions have shown that participants with high-risk features by gene array studies tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. Researchers at MIRT think that one reason for this is 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

Frits van Rhee, MD, PhD

Principal Investigator

UAMS

Eligibility Criteria

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.

Inclusion Criteria

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.

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Exclusion Criteria

I haven't had cancer before, except for certain skin cancers or cervical cancer that's been treated.

My condition is not considered high-risk.

Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Subjects of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

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Treatment Details

Interventions

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

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MEL--VTD-PACEExperimental Treatment8 Interventions

Melphalan, Velcade, Thalidomide, Dexamethasone, Cisplatin, Adriamycin, Cyclophosphamide and Etoposide