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Poster display session

4931 - A multicenter, randomized, phase 3 study of pomalidomide and dexamethasone (Pom-dex) with or without daratumumab in patients with relapsed or refractory multiple myeloma (RRMM): APOLLO


09 Sep 2017


Poster display session


Cancers in Adolescents and Young Adults (AYA);  MDS/MPN/Others


Evangelos Terpos


Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373


E. Terpos1, M.A. Dimopoulos1, E. Kastritis1, J.M. Schecter2, J. Ukropec3, E. Smith4, P. Sonneveld5

Author affiliations

  • 1 Department 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
  • 5 Department Of Hematology, Erasmus MC, Rotterdam/NL


Abstract 4931


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 provided by Janssen Research & Development


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.

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