Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial

Leukemia. 2020 Jul;34(7):1853-1865. doi: 10.1038/s41375-020-0724-1. Epub 2020 Feb 7.

Abstract

The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bortezomib / administration & dosage
  • Combined Modality Therapy
  • Consolidation Chemotherapy / mortality*
  • Cyclophosphamide / administration & dosage
  • Dexamethasone / administration & dosage
  • Female
  • Follow-Up Studies
  • Hematopoietic Stem Cell Transplantation / mortality*
  • Humans
  • Lenalidomide / administration & dosage
  • Maintenance Chemotherapy / mortality*
  • Male
  • Melphalan / administration & dosage
  • Multiple Myeloma / pathology
  • Multiple Myeloma / therapy*
  • Prognosis
  • Prospective Studies
  • Remission Induction
  • Survival Rate
  • Thalidomide / administration & dosage
  • Transplantation, Autologous

Substances

  • Thalidomide
  • Bortezomib
  • Dexamethasone
  • Cyclophosphamide
  • Lenalidomide
  • Melphalan