Navigation Links
Low-Dose Steroid Combined With Lenalidomide Prolongs Survival,Compared With High-Dose Steroid for Multiple Myeloma Treatment

WASHINGTON, April 4, 2007-Preliminary results from a large, randomized clinical trial for patients with newly diagnosed multiple myeloma, a cancer typically found in bone marrow, has shown that the use of a low dose of the steroid dexamethasone (Decadron ®), in combination with lenalidomide (Revlimid ®) is associated with improved survival when compared to a treatment regimen with lenalidomide and a higher, standard dose of dexamethasone. The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).

The data monitoring committee overseeing the trial (known as E4A03) recommended that the survival results from a recent interim analysis be made public because of early differences being seen in overall survival rates. Researchers found that patients in the study who received low-dose dexamethasone and lenalidomide had a one-year survival of 96 percent compared to 86 percent for patients treated with the standard-dose of dexamethasone and lenalidomide. In addition, there were fewer side effects associated with the low-dose dexamethasone and lenalidomide. Detailed results from this trial will be presented at the American Society of Clinical Oncology annual meeting in Chicago, Ill., from June 1 to 5, 2007.

These results have major implications for myeloma therapy, noted study chair Vincent Rajkumar, M.D., Mayo Clinic, Rochester, Minn. The results of this study, particularly lenalidomide plus low-dose dexamethasone, are very positive and in my opinion represent a real step forward in the treatment of this disease.

A total of 445 patients with newly diagnosed multiple myeloma, who had not previously received chemotherapy, were enrolled in this study between 2004 and 2006. Patients were randomized to one of two treatment arms. One patient group receive d lenalidomide and dexamethasone given at standard doses. The second group received standard-dose lenalidomide and low-dose dexamethasone. The primary objective was to determine if the low-dose arm would have similar response rates and lower toxicity than the standard-dose arm.

Randomized trials are the gold standard for evaluation of the effectiveness of new treatments, said NCI Director John E. Niederhuber, M.D. These results also emphasize once again the importance of NCIs rigorous program of oversight, which brings highly qualified clinician scientists to serve as members of data safety and monitoring committees.

Lenalidomide, a derivative of thalidomide, was approved by the U.S. Food and Drug Administration in 2006 to be used in combination with dexamethasone for the treatment of multiple myeloma in patients who received at least one prior therapy for their disease. Dexamethasone is a steroid that acts as an anti-inflammatory and as an immunosuppressant and has numerous uses in medical practice.

ECOG has a long history in developing new treatments for multiple myeloma, according to Robert L. Comis, M.D., ECOG group chairperson. The application of this effective and less toxic approach will benefit many patients with this disease.

Celgene, Inc., Summit, N.J., which manufactures lenalidomide, provided lenalidomide for the trial under a Cooperative Research and Development Agreement with NCI for the clinical development of lenalidomide.

Multiple myeloma is a cancer of plasma cells that are found in blood and bone marrow. In 2007, an estimated 19,900 people in the United States will be diagnosed with multiple myeloma and an estimated 10,790 people will die of the disease.

For more information about multiple myeloma, visit the NCI website at

For more information about cancer, please visit the NCI website at, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

Reference: E4A03: A Randomized Phase III Study of CC-5013 plus Dexamethasone vs. CC-5013 plus Low Dose Dexamethasone in Multiple Myeloma with Thalidomide plus Dexamethasone Salvage Therapy for Non-responders.

NCI Office of Media Relations

Related medicine technology :

1. ECOG Phase III Newly Diagnosed Multiple Myeloma Trial (E4A03) Reports Lenalidomide Plus Low-Dose Dexamethasone Suggests Survival Advantage for Patients with Multiple Myeloma
2. Valopicitabine Combined with Standard of Care Cleared Hepatitis C Virus in 72% of Patients Who Completed 12 Weeks of Treatment in a Phase II Trial
3. New Data Show Pfizers Axitinib Prolonged Overall Survival in Advanced Pancreatic Cancer When Combined with Standard of Care Chemotherapy
4. Investigational Cancer Drug Pertuzumab Shows Promising Results in Advanced Breast Cancer When Combined with Herceptin
5. Oncophage Cancer Vaccine Significantly Prolongs Recurrence-Free Survival by 45 Percent in Patients With Intermediate-Risk Kidney Cancer
6. Hyperthermia Plus Chemotherapy Nearly Doubles Disease-Free Survival Compared to Chemotherapy Alone for Sarcoma Cancer Patients
7. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
8. Velcade (Bortezomib) for Injection Based Therapies Produced Complete Remission Rates as High as 54 Percent in Patients With Previously Treated Multiple Myeloma
9. Velcade (bortezomib) for Injection Based Therapies Achieved Survival Rates as High as 100 Percent in Newly Diagnosed Multiple Myeloma Patients
10. Gentiums Defibrotide Seen as Active in Multiple Myeloma
11. ACE-011 Improves Multiple Myeloma Bone Disease in a Preclinical Model
Post Your Comments:
(Date:11/25/2015)... , Nov. 25, 2015  ARKRAY USA ... continues to provide evidence demonstrating the accuracy of its ... Congress on Insulin Resistance, Diabetes and Cardiovascular Disease in ... both the Company,s GLUCOCARD ® 01 meter and ... accuracy requirements. The ability to accurately measure glucose levels ...
(Date:11/25/2015)... 2015  Trovagene, Inc. (NASDAQ: TROV ), a ... Executive Officer Antonius Schuh, Ph.D., is scheduled to present ... Piper Jaffray Healthcare Conference. th Annual ... Hotel in New York on ... Schuh will be available for one-on-one meetings during the ...
(Date:11/25/2015)... , Nov. 25, 2015 USP ... hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, ... veterinary technicians). The chapter also covers all entities ... (e.g., pharmacies, hospitals, other healthcare institutions, patient treatment ... --> --> What ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Brillianteen, ... friendships, and learning in its 65th Anniversary Brillianteen Revue, scheduled for March 4-6, ... , For 65 years, Brillianteen has been a treasured tradition for numerous families ...
(Date:11/25/2015)... ... November 25, 2015 , ... Castlewood Treatment Center for Eating ... disorders as a result of the $20,000 raised at the center’s recent ... Golf Club in Eureka, will help individuals who otherwise might not seek treatment ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely ... resulting in a way for homeless people to have a more dignified and ... new initiative whereby they are repurposing plastic bags into sleeping mats for the ...
(Date:11/25/2015)... ... November 25, 2015 , ... Students and parents have something to be thankful ... Create Real Impact awards. California Casualty is proud to support the contest ... distracted and reckless driving, the number one killer of young drivers. , Almost ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Dr. Todd S. ... offer laser services to many of his patients. Dr. Afferica now uses the BIOLASE ... reduce the amount of time the doctor uses other traditional cutting tools, such as ...
Breaking Medicine News(10 mins):