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Revlimid Maintenance Therapy Significantly Extends Disease-Free Survival

By: Alyssa Liguori; Published: December 22, 2009 @ 3:42 pm | Comments Disabled

Preliminary results from a Phase 3 clinical trial show that multiple myeloma patients who received Revlimid [1] (lenalidomide) following a stem cell transplant had a significantly longer period of disease-free survival compared with a placebo group.

The trial (known as CALGB 100104) began with 568 multiple myeloma patients ages 18 to 70 years. No patients had a prior transplant or were treated for myeloma for longer than a year.

All participants received an autologous stem cell transplant, in which their own stem cells were collected prior to high-dose chemotherapy with melphalan [2] (Alkeran) and then the stem cells were transplanted after chemotherapy. Patients who did not respond to treatment or who experienced serious side effects were removed from the study.

The remaining 460 patients were randomized to receive Revlimid maintenance therapy or placebo. Patients in each group started treatment about 100 days after their transplant and continued receiving the drug until they showed signs of progressive disease.

Based on the number of patients in the placebo group who had signs of disease progression, the researchers estimated that half of the participants in this group would experience disease progression within 778 days, a little over two years. Patients receiving Revlimid maintenance therapy experienced significantly longer periods of progression-free survival. Not enough participants in this group have experienced progression to estimate the median time to disease progression.

“The primary objective [delay in time to disease progression] has been met based on the initial analysis,” said Dr. Philip McCarthy, associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this trial.

Due to the significant difference in time to progression between the two groups, the study has been stopped, patients have been informed about which maintenance therapy they were receiving, and all patients have been given the option to receive Revlimid.

The study has not yet demonstrated an increase in overall survival time from using Revlimid maintenance therapy.

Results of this trial will be submitted for publication in a journal in the upcoming year, and the investigators plan to present more detailed results at a national conference in 2010.

“We are very excited about the results,” added Dr. McCarthy. “We think this will be a major advance in the treatment of myeloma patients.”

Another clinical trial studying Revlimid as a maintenance therapy is expected to begin recruiting participants in 2010, said Dr. McCarthy, who is a member of the study’s protocol team. The study (known as BMT CTN 0702) will examine the following transplant regimens: a single autologous transplant, a single autologous transplant followed by chemotherapy, and a tandem autologous transplant. Each transplant regimen will be followed by Revlimid maintenance therapy for 3 years. This study will compare progression free survival time between the three treatment groups.

“We are very excited to be able to have so many trials to offer to myeloma patients and to advance the treatment of this disease,” said Dr. McCarthy.

For more information about the CALGB 100104 results, please see the National Cancer Institute [3] press release. To hear Dr. McCarthy speak about this trial as well as the upcoming BMT CTN 0702 trial, please see the Myeloma Intergroup video [4].


Article printed from The Myeloma Beacon: https://myelomabeacon.org

URL to article: https://myelomabeacon.org/news/2009/12/22/revlimid-maintenance-therapy-significantly-extends-disease-free-survival/

URLs in this post:

[1] Revlimid: https://myelomabeacon.org/resources/2008/10/15/revlimid/

[2] melphalan: https://myelomabeacon.org/resources/2008/10/15/melphalan/

[3] National Cancer Institute: http://www.nih.gov/news/health/dec2009/nci-18.htm

[4] Myeloma Intergroup video: http://www.cibmtr.org/SERVICES/Clinical_Trials/BMTCTN/MyelomaVideo/index.html

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