Questions About Cancer? 1-800-4-CANCER

Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 08/28/2007

Drug Combination Shows Benefit in Relapsed/Refractory Multiple Myeloma

Adapted from the NCI Cancer Bulletin 1.

Interim results from a phase III clinical trial suggest a new combination treatment should be another standard of care for patients with relapsed or refractory multiple myeloma, according to the trial's leaders.

In the most recent survival analysis from the 646-patient trial, the combination of pegylated liposomal doxorubicin 2 (Doxil®) and bortezomib 3 (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 4).

The results come two years after a phase III trial (see related story 5) 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 6 (Revlimid®) and dexamethasone was superior to dexamethasone alone in patients with refractory or relapsed disease.

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 7), 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.

Related Pages



Glossary Terms

dexamethasone (DEK-suh-MEH-thuh-sone)
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.
disease progression (dih-ZEEZ pruh-GREH-shun)
Cancer that continues to grow or spread.
high grade (hy grayd)
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.
median (MEE-dee-un)
A statistics term. The middle value in a set of measurements.
neutropenia (noo-troh-PEE-nee-uh)
A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).
phase III trial (fayz … TRY-ul)
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.
refractory (reh-FRAK-tor-ee)
In medicine, describes a disease or condition that does not respond to treatment.
relapse (REE-laps)
The return of a disease or the signs and symptoms of a disease after a period of improvement.
standard of care (STAN-durd ... kayr)
Treatment that experts agree is appropriate, accepted, and widely used. Also called best practice, standard medical care, and standard therapy.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.cancer.gov/cancertopics/druginfo/doxorubicin-hydrochloride-liposome
3http://www.cancer.gov/cancertopics/druginfo/bortezomib
4http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&T
ermToSearch=17679727&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pu
bmed_ResultsPanel.Pubmed_RVDocSum
5http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_062805/page5#b
6http://www.cancer.gov/cancertopics/druginfo/lenalidomide
7http://www.cancer.gov/clinicaltrials/search/view?cdrid=420968&version=Healt
hProfessional&protocolsearchid=3538044
8http://www.cancer.gov/clinicaltrials/search
9http://www.cancer.gov/cancertopics/types/myeloma