1035TiP - A multicenter, randomized, phase 3 study of pomalidomide and dexamethasone (Pom-dex) with or without daratumumab in patients with relapsed or refra...

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancer in Adolescents
Myeloproliferative Neoplasms
Haematologic Malignancies
Presenter Evangelos Terpos
Citation Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373
Authors E. Terpos1, M.A. Dimopoulos1, E. Kastritis1, J.M. Schecter2, J. Ukropec3, E. Smith4, P. Sonneveld5
  • 1Department Of Clinical Therapeutics, National And Kapodistrian University Of Athens, School Of Medicine, “Alexandra” General Hospital, - - Athens/GR
  • 2-, Janssen Research & Development, Raritan/US
  • 3-, Janssen Scientific Affairs, Horsham/US
  • 4-, Janssen Research & Development, High Wycombe/GB
  • 5Department Of Hematology, Erasmus MC, Rotterdam/NL

Abstract

Background

Daratumumab (DARA), a human IgGκ monoclonal antibody targeting CD38, is approved in the United States and Europe for use in patients with RRMM, as a monotherapy and in combination with bortezomib/dexamethasone or lenalidomide/dexamethasone. In a phase 1b study, DARA plus pomalidomide and low-dose dexamethasone (Pom-dex) demonstrated efficacy and tolerability in patients with RRMM. Here, the safety and efficacy of DARA plus Pom-dex is evaluated in a phase 3 study.

Trial design

This is an ongoing, phase 3, multicenter, randomized, open-label study of DARA plus Pom-dex versus Pom-dex alone. Adults with RRMM who have received and responded to prior anti-myeloma therapy, including a proteasome inhibitor and a lenalidomide-containing regimen, and who have progressed on their last regimen are eligible. Patients who have received 1 prior line of therapy must have progressed ≤60 days of completing the lenalidomide-containing regimen. Patients will be randomized 1:1 to receive Pom 4 mg orally on Days 1-21 of a 28-day cycle plus dex 40 mg weekly (20 mg for patients ≥75 year of age), with or without intravenous DARA 16 mg/kg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and monthly thereafter, until progression or unacceptable toxicity. To mitigate potential infusion-related reactions, all patients will receive pre-infusion medications (including dexamethasone, paracetamol, diphenhydramine, and an optional leukotriene inhibitor) and patients with a higher risk of respiratory complications will receive post-infusion medications (including diphenhydramine, a short-acting β2 adrenergic receptor agonist, and lung disease control medications). Safety evaluations will occur weekly during Cycles 1-2, every other week during Cycles 3-6, and monthly thereafter. Disease evaluations will occur monthly. The primary endpoint is progression-free survival. Secondary endpoints include safety, overall response rate, minimal-residual-disease-negative rate, duration of response, and overall survival. Approximately 302 patients will be enrolled across 10 countries.

Clinical trial identification

Eudractnr: 2017-001618-27

Legal entity responsible for the study

Janssen Research & Development, LLC

Funding

Funding provided by Janssen Research & Development

Disclosure

E. Terpos: Consultancy & Honoraria: Genesis, Bristol-Myers Squibb, Janssen, Takeda, Amgen. Honoraria: Celgene, Novartis. Research Funding: Genesis, Janssen, Amgen. M.A. Dimopoulos: Consultancy & Honoraria: Celgene, Janssen, Takeda, Amgen. E. Kastritis: Honoraria: Janssen, Celgene, Genesis, Takeda, Millennium-Takeda, Janssen-Cilag, Pharmacyclics. Research Funding: Novartis. J.M. Schecter: Employment & Equity: Janssen. J. Ukropec, E. Smith: Employment: Janssen. P. Sonneveld: Consultancy & Research Funding & Honoraria: Amgen, Celgene, Janssen, Karyopharm, Takeda.