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NCT02348528

Open-label Extended Access Program on Lenalidomide Plus Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma Who Participated in CC-5013-MM021 for at Least 1 Year

Completed Phase 2 Last updated 12 November 2019
What this trial tests

Phase 2 trial testing Lenalidomide in Multiple Myeloma in 65 participants. Completed in 29 September 2016.

Timeline
11 September 2012
Primary endpoint
29 September 2016
29 September 2016

Quick facts

Lead sponsorCelgene
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment65
Start date11 September 2012
Primary completion29 September 2016
Estimated completion29 September 2016
Sites11 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who participated in Study CC-5013-MM-021. For subjects who remained progression free under Rd treatment of Study CC-5013-MM-02 1, this LAP offers the option to continue lenalidomide treatment for subjects who have shown therapeutic benefit.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program.
    Du X, Jin J, Cai Z, Chen F, et al · · 2016 · cited 2× · PMID 26821931 · DOI 10.1186/s12885-016-2069-8

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