CALGB 100104 — Lenalidomide Maintenance Versus Placebo After Autologous Stem-Cell Transplantation in Multiple Myeloma

Phase 3 · 2012 · Multiple Myeloma

Design

Randomized lenalidomide vs placebo maintenance beginning ~100 days after autologous stem-cell transplant, continued until progression.

Population

Multiple myeloma patients with stable disease or better after first autologous transplant.

Primary Endpoint

time to progression (TTP)

Key Result

TTP roughly doubled and overall survival improved with lenalidomide maintenance despite an increase in second primary malignancies.

Guideline Impact

Basis for FDA approval and NCCN category 1 lenalidomide maintenance post-transplant in myeloma