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

Sundar Jagannath, Leonard T. Heffner, Sikander Ailawadhi, Nikhil C. Munshi, Todd M. Zimmerman, Jacalyn Rosenblatt, Sagar Lonial, Asher Chanan-Khan, Markus Ruehle, Faiza Rharbaoui, Thomas Haeder, Andrea Wartenberg-Demand, Kenneth C. Anderson

Research output: Contribution to journalArticlepeer-review

33 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)372-380
Number of pages9
JournalClinical Lymphoma, Myeloma and Leukemia
Issue number6
StatePublished - Jun 2019


  • Antibody-drug conjugate
  • CD138
  • Monoclonal antibody
  • Multiple-dose
  • Syndecan-1

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research


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