1036TiP - Phase 2, Multicenter, Single-Arm, Open Label Study Evaluating the Combination of Daratumumab + Cyclophosphamide, Bortezomib and Dexamethasone (Dara...

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancer in Adolescents
Myeloproliferative Neoplasms
Haematologic Malignancies
Presenter Manish Sharma
Citation Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373
Authors M. Sharma1, L. Ey2, H. Parros3, S. Murphy2, M. Darif4, A. Londhe4, J. Ukropec5, M. Qi6, Y. Lutska2, T. Lin2, S. Gunawardena2
  • 1Med Group Oncology, Janssen Pharmaceuticals, 19044 - Horsham/US
  • 2Med Group Oncology, Janssen Pharmaceuticals, Horsham/US
  • 3Clinical Trials Operations, Janssen Research & Development, LLC, Titusville/US
  • 4Clinical Biostats, Janssen Research & Development, LLC, Titusville/US
  • 5Oncology, Janssen Research & Development, LLC, Horsham/US
  • 6Clinical Oncology, Janssen Research & Development, LLC, Spring House/US

Abstract

Background

Dara is a monoclonal anti-CD38 antibody approved for the treatment of relapsed and refractory MM. Addition of dara to bortezomib and dexamethasone increased complete and overall response rates and improved progression-free survival (PFS) in pts with relapsed MM. CyBorD is a bortezomib based regimen which has been shown to be an effective therapy for MM. This study was designed to evaluate the combination of Dara-CyBorD in pts with MM who are previously untreated or have relapsed MM following only one line of prior therapy.

Trial design

This is a multicenter, single-arm, open label, Phase 2 study in pts with MM who have received ≤ 1 line of prior therapy. Approximately 100 pts (≥40 with untreated MM and ≥40 with relapsed MM) will receive Dara-CyBorD every 28 days for 4 to 8 cycles. Pts receive oral cyclophosphamide 300 mg/m2 on Days 1, 8, 15, and 22; subcutaneous bortezomib 1.5 mg/m2 on Days 1, 8, and 15; and oral or IV dexamethasone 40 mg weekly. Dara is administered concurrently on 28 day cycles at a dose of 8 mg/kg IV on Days 1 and 2 of Cycle 1, then 16 mg/kg IV weekly from Cycle 1 Day 8 through completion of Cycle 2. For Cycles 3-6, pts receive dara 16 mg/kg IV once every 2 weeks. From Cycle 7 onward, pts receive dara 16 mg/kg IV once every 4 weeks, whether with CyBorD or alone during the maintenance phase. Pts receive 4 to 8 induction cycles of Dara-CyBorD and eligible pts may undergo an autologous stem cell transplant. All eligible pts then receive 12 cycles of maintenance therapy with dara 16 mg/kg IV every 28 days. The primary endpoint is complete response (CR) plus very good partial response (CR+VGPR) following 4 cycles of induction therapy with Dara-CyBorD. Secondary endpoints include overall response rate (CR+VGPR+PR), time to VGPR and partial response, duration of response, PFS, overall survival rate, infusion reaction profile of split-dose infusions and safety. Inclusion criteria include ≥ 18 years of age; documented MM per IMWG 2015 criteria; an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2; no or one prior line of therapy. The estimated primary endpoint analysis date is February 2018.

Clinical trial identification

NCT02951819

Legal entity responsible for the study

Janssen Scientific Affairs, LLC

Funding

Janssen Scientific Affairs, LLC

Disclosure

M. Sharma, L. Ey, H. Parros, S. Murphy, M. Darif, A. Londhe, J. Ukropec, M. Qi, Y. Lutska, T. Lin, S. Gunawardena: Author discloses employment with Janssen and Johnson & Johnson stock ownership.