REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with:...Multiple myeloma (MM), in combination with dexamethasone...MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT)

Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide is recommended as maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults...

Recommendations: Maintenance with lenalidomide is considered the standard of care for all MM patients post-ASCT [I, A].

Multiple Myeloma: Therapy for previously treated multiple myeloma…Other Recommended Regimens…Cyclophosphamide/lenalidomide/dexamethasone

Multiple Myeloma: Maintenance therapy...Preferred Regimens…Lenalidomide (category 1)

The NCCN Panel has included lenalidomide in combination with bendamustine and dexamethasone as a treatment option for relapsed/refractory MM.

The NCCN Panel has included cyclophosphamide/lenalidomide/dexamethasone as a primary therapy option for transplant-eligible patients with MM under the category "useful under certain cirumstances" (category 2A).

Multiple Myeloma: Useful In Certain Circumstances…Lenalidomede/dexamethasone (category 1)...

The phase 3 FIRST trial demonstrated significant improvement in progression‐free survival (PFS) and overall survival (OS) with an immune‐stimulatory agent, lenalidomide, in combination with low‐dose dexamethasone until disease progression (Rd continuous) vs melphalan +prednisone + thalidomide (MPT) in transplant‐ineligible patients with newly diagnosed multiple myeloma (NDMM)....Rd continuous demonstrated a significant improvement in PFS vs MPT (median, 29.3 vs 20.2 months; p = 0.03326; Figure 1) in the Canadian/US subgroup.

Patients with untreated symptomatic myeloma were randomly assigned in this open-label non-inferiority trial to lenalidomide 25 mg on days 1–21 plus dexamethasone 40 mg on days 1–4, 9–12, and 17–20 of a 28-day cycle (high dose)...Lenalidomide plus low-dose dexamethasone is associated with better short-term overall survival and with lower toxicity than lenalidomide plus high-dose dexamethasone in patients with newly diagnosed myeloma.

57 patients were assigned to treatment with lenalidomide and dexamethasone,..the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P=0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase....Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival.