Combination Chemotherapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byGareth Morgan, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

With this study - Total Therapy IIIB - researchers are extending the findings of Total Therapy III based what they have learned from the first two studies (Total Therapy I and II), with new research strategies designed to explore why chromosome abnormalities found in persons with multiple myeloma affect the outcome of drug therapy used in this disease."

Eligibility Criteria

This trial is for patients under 75 with newly diagnosed active Multiple Myeloma needing treatment. They can have had one cycle of chemotherapy, must be able to perform daily activities (performance status 0-2), and have decent heart and lung function. Pregnant women or those with serious health issues, recent heart problems, uncontrolled diabetes, severe lung disease, or a history of other cancers are excluded.

Inclusion Criteria

I am younger than 75 years old.

My blood or urine tests show abnormal protein levels, or I have significant bone marrow cancer cells.

My lung function tests are above 50% of what's expected, or I have an exception due to my condition.

See 5 more

Exclusion Criteria

You are allergic to bortezomib, boron, or mannitol.

Your platelet count is less than 30 x 10^9/L, unless it is related to myeloma.

My diabetes is not under control.

See 7 more

Treatment Details

Interventions

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

Trial OverviewTotal Therapy IIIB aims to improve outcomes in Multiple Myeloma by testing a combination of drugs: Cisplatin, Thalidomide, Dexamethasone, Adriamycin (Doxorubicin), Cyclophosphamide, Etoposide and Velcade (Bortezomib). It builds on previous Total Therapy studies to understand how chromosome abnormalities affect drug response.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: VDTPACEExperimental Treatment7 Interventions

Velcade, Dexamethasone, Thalidomide, Cisplatinin, Adriamycin, Cyclophosphamide and Etoposide