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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

Multiple Myeloma Clinical Trial

Official title:
A Multi-center, Open-label Extended Access Program of Lenalidomide Plus Low-dose Dexamethasone in Chinese Subjects With Relapsed/Refactory Multiple Myeloma Who Participated in Study CC-5013-MM-021 for at Least One Year.

Clinical Trial Summary

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.

Clinical Trial Description

After subjects who are still on treatment have completed at least 1 year of therapy in Study CC-5013-MM-021 (from the start date of lenalidomide treatment), the EAP will allow consented subjects who (1) have remained progression free under Rd treatment in Study CC-SO I3-MM-02 I to roll over to the Treatment Phase of the LAP to continue Rd treatment, and (2) have discontinued Rd therapy and are currently in the Long-Term Follow-up Phase in Study CC-5013-MM-021 to roll over to the Safety Follow-up Phase of the EAP for survival and SPM outcomes. The maximum duration of this LAP program is at least 5 years from the time the last on-study ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02348528
Study type Interventional
Source Celgene
Contact
Status Completed
Phase Phase 2
Start date September 11, 2012
Completion date September 29, 2016
View Details
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