Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Multiple Myeloma/Other Plasma Cell Neoplasms 2 NCI's gateway for information about multiple myeloma and other plasma cell neoplasms.

Adapted from the NCI Cancer Bulletin, vol. 4/no. 24, August 21, 2007 (see the current issue ³).

In the most recent survival analysis from the 646-patient trial, the combination of pegylated liposomal doxorubicin ⁴ (Doxil®) and bortezomib ⁵ (Velcade®) improved the median time to disease progression compared with bortezomib alone (9.3 months vs. 6.5 months) and yielded a superior 15-month overall survival rate (76 percent of patients in the combination group were alive at 15 months compared with 65 percent in the bortezomib-only group). The report, to be published in the Sept. 1, 2007, Journal of Clinical Oncology, was released early online Aug. 6, 2007 (see the journal abstract ⁶).

The results come two years after a phase III trial (see related story ⁷) that showed bortezomib alone was superior to dexamethasone, another drug commonly used to treat all stages of multiple myeloma, and one year after a trial demonstrated that the combination of lenalidomide ⁸ (Revlimid®) and dexamethasone was superior to dexamethasone alone in patients with refractory or relapsed disease (see related story ⁹).

The bortezomib/Doxil combination also increased the duration of response, reported the study's principal investigator, Dr. Robert Z. Orlowski from the University of Texas M.D. Anderson Cancer Center, and colleagues. However, the combination's benefits came at the expense of an increased risk of adverse events, including high-grade hematologic (e.g., neutropenia) and gastrointestinal (e.g., diarrhea, nausea) toxicities.

Based on the results of this trial, also known as the DOXIL-MMY-3001 study (see the protocol summary ¹⁰), the U.S. Food and Drug Administration recently approved the use of this combination for treating patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

Glossary Terms

A synthetic steroid (similar to steroid hormones produced naturally in the adrenal gland). Dexamethasone is used to treat leukemia and lymphoma and may be used to treat some of the problems caused by other cancers and their treatment.

Cancer that continues to grow or spread.

A term used to describe cells that look abnormal under a microscope. These cells are more likely to grow and spread quickly than cells in low-grade cancer or in growths that may become cancer.

A statistics term. The middle value in a set of measurements.

A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

In medicine, describes a disease or condition that does not respond to treatment.

The return of signs and symptoms of cancer after a period of improvement.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with the standard of care. Also called best practice and standard therapy.