1038TiP - Phase 2 Randomized Study of Daratumumab (dara), Lenalidomide (R), Bortezomib (V), and Dexamethasone (d; Dara-RVd) vs. RVd in Patients (Pts) with Ne...

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancer in Adolescents
Myeloproliferative Neoplasms
Haematologic Malignancies
Presenter Thomas Lin
Citation Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373
Authors T. Lin1, L. Hydutsky2, H. Parros3, S. Murphy4, H. Pei5, A. Londhe5, J. Ukropec6, M. Qi7, Y. Lutska4, M. Sharma1
  • 1Med Group Oncology, Janssen Pharmaceuticals, 19044 - Horsham/US
  • 2Mastt/pmc, Janssen Pharmaceuticals, Horsham/US
  • 3Clinical Trials Operations, Janssen Research & Development, LLC, Titusville/US
  • 4Med Group Oncology, Janssen Pharmaceuticals, Horsham/US
  • 5Clinical Biostats, Janssen Research & Development, LLC, Titusville/US
  • 6Oncology, Janssen Research & Development, LLC, Horsham/US
  • 7Clinical Oncology, Janssen Research & Development, LLC, Spring House/US

Abstract

Background

Dara is an anti-CD38 antibody approved for the treatment of relapsed and refractory MM. Addition of dara to Vd and Rd improved complete (CR) and overall response (OR) rates and progression-free survival (PFS) in relapsed MM. RVd followed by HDT and ASCT achieves high response rates in previously untreated MM. The primary objective of this study is to determine if the addition of dara to RVd will increase the stringent CR (sCR) rate by the end of post-ASCT consolidation therapy.

Trial design

This is a multicenter, randomized, open-label, active-controlled study in newly diagnosed MM pts eligible for HDT and ASCT. Following a safety run-in for up to 16 pts to assess dose limiting toxicities, 200 additional pts will be randomized 1:1 to Dara-RVd or RVd. Pts receive 4 induction cycles of RVd +/- dara; followed by stem cell mobilization, HDT, and ASCT; 2 consolidation cycles of RVd +/- dara; and maintenance therapy with Rd +/- dara for 24 months. During induction and consolidation (cycles 1-6), all pts receive R 25 mg orally on Days 1-14; V 1.3 mg/m2 subcutaneously on Days 1, 4, 8 and 11; and d 40 mg weekly; every 21 days. In the Dara-RVd group only, dara 16 mg/kg IV is given on Days 1, 8 and 15 of cycles 1-4 and on Day 1 of cycles 5-6. During maintenance, all pts receive R 10 mg daily on Days 1-21 every 28 days and d 20 mg every 56 days; dara 16 mg/kg IV is given every 56 days in the Dara-RVd group only. Inclusion criteria include age 18-70 years; eligibility for HDT and ASCT; documented MM; ECOG score of 0-2; adequate organ function; and no prior systemic therapy for MM. The primary endpoint is the sCR rate by the end of post-ASCT consolidation therapy. Secondary endpoints include rates of OR, CR, sCR, VGPR, and minimal residual disease negative status after induction, ASCT, consolidation and maintenance; time to initial response, VGPR, CR and sCR; duration of response; PFS; and overall survival. The study is being conducted at Alliance Foundation Trials (AFT) centers and other institutions in the US. The study has completed the 16 pt safety run-in phase and is currently enrolling pts in the randomized phase.

Clinical trial identification

NCT02874742

Legal entity responsible for the study

Janssen Research & Development, LLC

Funding

Janssen Research & Development, LLC

Disclosure

T. Lin, H. Parros, S. Murphy, H. Pei, A. Londhe, J. Ukropec, M. Qi, Y. Lutska, M. Sharma: Employment with Janssen and Johnson & Johnson stock ownership. L. Hydutsky: Employment with Janssen and Johnson & Johnson stock ownership.