Melflufen plus dexamethasone in relapsed/refractory multiple myeloma: long-term survival follow-up from the Phase II study O-12-M1

Br J Haematol. 2021 Jun;193(6):1105-1109. doi: 10.1111/bjh.17302. Epub 2021 Jan 6.

Abstract

An updated survival analysis was conducted for the Phase II study O-12-M1 of melphalan flufenamide (melflufen) plus dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) with two or more prior lines of therapy (including bortezomib and lenalidomide). Partial response or better was seen in 31%. After a 46-month median overall survival (OS) follow-up, melflufen plus dexamethasone had a median OS of 20·7 months (75th percentile OS, 47·5 months). The median time-to-next treatment for melflufen plus dexamethasone was 7·9 months. In summary, melflufen plus dexamethasone resulted in sustained long-term clinical benefit in patients with RRMM.

Keywords: melflufen; melphalan flufenamide; multiple myeloma; relapsed/refractory multiple myeloma.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Dexamethasone / administration & dosage
  • Dexamethasone / adverse effects
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Melphalan / administration & dosage
  • Melphalan / adverse effects
  • Melphalan / analogs & derivatives
  • Middle Aged
  • Multiple Myeloma* / drug therapy
  • Multiple Myeloma* / mortality
  • Phenylalanine / administration & dosage
  • Phenylalanine / adverse effects
  • Phenylalanine / analogs & derivatives
  • Survival Rate

Substances

  • melflufen
  • Phenylalanine
  • Dexamethasone
  • Melphalan