Phase III Study Confirms Benefits of Lenalidomide Maintenance Therapy for Patients with Multiple Myeloma

BUFFALO, N.Y. — A large cooperative-group study directed by the Alliance for Clinical Trials in Oncology has confirmed previous evidence that the drug lenalidomide delays time to disease progression for patients with multiple myeloma and is an important treatment option for patients with this rare but increasingly common cancer of the blood and marrow. Updated results of the ongoing study, which is led by Philip McCarthy, MD, and Sarah Holstein, MD, PhD, of Roswell Park Comprehensive Cancer Center, will be highlighted during a poster discussion session at the American Society of Clinical Oncology (ASCO) 51^st Annual Meeting in Chicago.

This randomized phase III study compares maintenance, or ongoing, therapy with lenalidomide (Revlimid) following autologous stem-cell transplant in patients newly diagnosed with multiple myeloma. The trial’s 461 participants, all under 70 years old, showed evidence of stable or controlled disease at 100 days post-transplant before they were randomly assigned to either the treatment arm or the placebo arm. While incidence of second primary malignancies was elevated among patients who received lenalidomide, the researchers found a marked benefit for those receiving maintenance doses of the drug.

“The results demonstrate that maintenance therapy with lenalidomide significantly improves both time to disease progression and overall survival, and that these benefits apply regardless of whether patients were in complete response at randomization or whether they had previously received thalidomide or lenalidomide as induction therapy,” says Dr. Holstein, Assistant Professor of Oncology in Roswell Park’s Department of Medicine, the study’s first and presenting author.

Estimated median time to progression was nearly doubled for those receiving treatment, from 27 months for the placebo group to 53 months for those receiving lenalidomide. After 65 months median follow-up, the median overall survival has not yet been reached for those receiving lenalidomide and is 76 months for the placebo group. Among those receiving treatment, 25 secondary primary malignancies were observed, compared to 10 in the placebo arm. The study was unblinded at 18 months median follow-up, and 86 patients from the placebo arm who showed no evidence of disease progression chose to cross over to the treatment group. 

“Our findings provide compelling evidence that this treatment approach represents advancement in our ability to control this disease and generate better outcomes for patients with multiple myeloma,” notes the study’s senior author, Dr. McCarthy, who is Professor of Oncology and Director of the Blood & Marrow Transplant Program at Roswell Park.

The study, “Updated analysis of CALGB/ECOG/BMT CTN 100104: Lenalidomide (Len) vs. placebo (PBO) maintenance therapy after single autologous stem cell transplant (ASCT) for multiple myeloma (MM),” is abstract 8523 and will be presented on board no. 340 during the Lymphoma and Plasma Cell Disorders poster session Sunday, May 31, from 8 a.m. to 11:30 a.m. CDT in McCormick Place, S Hall A, and will also be featured in a poster discussion session later that day, from 4:30 p.m. to 5:45 p.m. CDT in McCormick Place E354b.

The research, which is supported by grants from the National Institutes of Health and National Cancer Institute (project nos. U10CA180821, U10CA180882, U01HL069294, U10CA21115, U10CA031946 and U10CA33601) is a collaborative effort among three hematologic research groups: CALGB/The Alliance for Clinical Trials in Oncology, the Eastern Cooperative Oncology Group (ECOG) and the Bone Marrow Transplant Clinical Trials Network (BMT-CTN).

Founded in 1964, ASCO is the world’s leading professional organization representing physicians who care for people with cancer. ASCO 2015 began May 29 and continues through June 2 at McCormick Place, Chicago, Ill., bringing together some 30,000 oncology professionals from around the world. 

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The mission of Roswell Park Comprehensive Cancer Center is to understand, prevent and cure cancer. Founded in 1898, Roswell Park is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email AskRoswell@Roswellpark.org. Follow Roswell Park on Facebook and Twitter.