REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial. It is not known if REVLIMID is safe and effective in children.
After a stem cell
REVLIMID is the only multiple myeloma treatment FDA approved for maintenance therapy after an auto-HSCT.
Clinical trials include 2 studies of REVLIMID as a maintenance therapy after an auto-HSCT.
Clinical trials in patients receiving REVLIMID Maintenance therapy following an autologous hematopoietic stem cell transplant (auto-HSCT) versus no maintenance therapy.
Two studies (Study 1: 460 patients; Study 2: 614 patients) looked at the safety and effectiveness of REVLIMID as a maintenance therapy after an autologous hematopoietic stem cell transplant (a type of stem cell transplant that uses your own stem cells). Half of the patients were treated with REVLIMID every day until the disease progressed, side effects became intolerable, or patients withdrew for another reason. The other half received no maintenance treatment.
Patients who took REVLIMID maintenance therapy experienced:
Longer progression-free survival (PFS)
Studies 1 and 2 evaluated PFS—how long a patient lives without the disease getting worse.
STUDY 1 (UNITED STATES)
Study 1, conducted in the United States, showed that the median* PFS for patients on REVLIMID maintenance therapy was 3.8 years longer than for patients who received no maintenance therapy.
STUDY 2 (EUROPE)
Study 2, conducted in Europe, showed that the median* PFS for patients on REVLIMID maintenance therapy was 1.9 years longer than for patients who received no maintenance therapy.
Additional results of studies of REVLIMID as maintenance therapy.
These studies were not designed to evaluate overall survival (OS)—the length of time patients were alive following the start of treatment. Therefore, it cannot be concluded that REVLIMID caused the differences observed between the 2 groups.
The most common side effects of REVLIMID include: diarrhea, rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet, and skin, sleep problems (insomnia), headache,† muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of a cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed,† shaking or trembling (tremor), joint aches,† and pain in your back or stomach area (abdomen).
†Occurred in (≥5%)
*“Median” means half of the patients had a higher result while half of the patients had a lower result.
Lenalidomide (REVLIMID) is the only FDA-approved maintenance therapy recommended for multiple myeloma by the National Comprehensive Cancer Network® (NCCN®).
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)® for Multiple Myeloma V.3.2021. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed October 19, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.
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