Indatuximab Ravtansine (BT062) Monotherapy in Patients With Relapsed and/or Refractory Multiple Myeloma

Clin Lymphoma Myeloma Leuk. 2019 Jun;19(6):372-380. doi: 10.1016/j.clml.2019.02.006. Epub 2019 Feb 21.


Background: Indatuximab ravtansine (BT062) is an antibody-drug conjugate that binds to CD138, which is overexpressed on multiple myeloma (MM) cells.

Patients and methods: We report from 2 clinical studies of patients with relapsed and/or refractory MM previously treated with an immunomodulatory drug and a proteasome inhibitor. Single- and multi-dosing schedules were investigated to define dose-limiting toxicities, maximum tolerated dose (MTD), recommended phase II dose, and to describe safety, efficacy, and pharmacokinetics.

Results: In the first-in-human study, indatuximab ravtansine was administered to 32 patients on day 1 of each 21-day cycle. The MTD was 160 mg/m2. In the phase I/IIa study, indatuximab ravtansine was administered to 35 patients on days 1, 8, and 15 of each 28-day cycle, and the MTD/recommended phase II dose was 140 mg/m2. Most (88%) adverse events were grade 1 or 2, the most common being diarrhea and fatigue. There was rapid clearance of indatuximab ravtansine and no relevant accumulation. Over 75% of heavily pretreated patients achieved stable disease or better. With the multi-dose schedule, minor and partial responses occurred in 14.7% of patients, the median time to progression was 3 months, and the median overall survival was 26.7 months.

Conclusion: Our data support further investigation of indatuximab ravtansine as part of a combination regimen for relapsed and/or refractory MM.

Keywords: Antibody-drug conjugate; CD138; Monoclonal antibody; Multiple-dose; Syndecan-1.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Immunological / administration & dosage
  • Antineoplastic Agents, Immunological / adverse effects
  • Antineoplastic Agents, Immunological / therapeutic use*
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Immunoconjugates / administration & dosage
  • Immunoconjugates / adverse effects
  • Immunoconjugates / therapeutic use*
  • Male
  • Maytansine / administration & dosage
  • Maytansine / adverse effects
  • Maytansine / analogs & derivatives
  • Maytansine / therapeutic use
  • Middle Aged
  • Multiple Myeloma / diagnosis
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / mortality
  • Neoplasm Grading
  • Neoplasm Staging
  • Recurrence
  • Treatment Outcome


  • Antineoplastic Agents, Immunological
  • Immunoconjugates
  • indatuximab ravtansine
  • Maytansine