• Active, not recruiting

NCT02076009: Phase 3 - Daratumumab, Lenalidomide & Dex (DRd) VS Len & Dexa (Rd) - MMY3003 (POLLUX)

Updated: Jun 15

MMY3003 (POLLUX) Study


NCT02076009: Phase 3: A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

pollux study

The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

JNJ-54767414


Sponsor

Janssen Research & Development, LLC


Multiple Locations

 

ClinicalTrials.gov Identifier: NCT02076009


Official Title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

First Posted : March 3, 2014


Click here for details on ClinicalTrials.gov

 

JNJ-54767414

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

N Engl J Med; 2016

Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma

Conclusions: The addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma. Daratumumab was associated with infusion-related reactions and a higher rate of neutropenia than the control therapy. (Funded by Janssen Research and Development; POLLUX ClinicalTrials.gov number, NCT02076009)

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Blood; 2022

Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA

These findings represent the first large-scale analysis with robust methodology to support ≥CR with MRD negativity as a prognostic factor for PFS in RRMM and TIE NDMM. These trials were registered at www.clinicaltrials.gov as NCT02076009, NCT02136134, NCT02195479, and NCT02252172.

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Br J Haematol; 2021

Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial

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J Clin Oncol; 2021

Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR

Conclusion: Daratumumab-based combinations induce higher rates of sustained MRD negativity versus standard of care, which are associated with durable remissions and prolonged clinical outcomes.

Trial registration: ClinicalTrials.gov NCT02136134 NCT02076009

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Haematologica; 2020

Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies

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Locations

United States, Arkansas

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