Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Over 75 Years Old with Alternating Bortezomib/dexamethasone and Lenalidomide/dexamethasone: the MARBLE Trial

Acta Med Okayama. 2019 Dec;73(6):547-552. doi: 10.18926/AMO/57722.

Abstract

Elderly multiple myeloma (MM) patients, who are generally ineligible for transplantation, have high risks of death and treatment discontinuation, and require a regimen incorporating novel agents that balance safety, tolerability, and efficacy. We evaluated alternating bortezomib-dexamethasone and lenalidomide-dexamethasone treatments administered over a 63-day cycle in transplant-ineligible elderly patients with newly diagnosed MM. Subcutaneous bortezomib 1.3 mg/m2 was administered weekly on Days 1, 8, 15, and 22; oral lenalidomide 15 mg daily on Days 36-56; and oral dexamethasone 20 mg on Days 1, 8, 15, 22, 36, 43, 50, and 57 for 6 cycles. The primary endpoint was the overall response rate.

Keywords: bortezomib; dexamethasone; lenalidomide; myeloma.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / therapeutic use
  • Antineoplastic Agents* / administration & dosage
  • Antineoplastic Agents* / therapeutic use
  • Bortezomib* / administration & dosage
  • Bortezomib* / therapeutic use
  • Clinical Trials, Phase II as Topic
  • Dexamethasone* / administration & dosage
  • Dexamethasone* / therapeutic use
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunologic Factors / administration & dosage
  • Immunologic Factors / therapeutic use
  • Lenalidomide* / administration & dosage
  • Lenalidomide* / therapeutic use
  • Male
  • Multicenter Studies as Topic
  • Multiple Myeloma* / drug therapy

Substances

  • Anti-Inflammatory Agents
  • Antineoplastic Agents
  • Bortezomib
  • Dexamethasone
  • Immunologic Factors
  • Lenalidomide