- Active, not recruiting
NCT02076009: Phase 3 - Daratumumab, Lenalidomide & Dex (DRd) VS Len & Dexa (Rd) - MMY3003 (POLLUX)
Updated: Jun 15, 2022
MMY3003 (POLLUX) Study
NCT02076009: Phase 3: A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
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
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)
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.
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
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
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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