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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide
DRUG	Dexamethasone

Timeline

• Start date: 2012-09-11
• Primary completion: 2016-09-29
• Completion: 2016-09-29
• First posted: 2015-01-28
• Last updated: 2019-11-12

Locations

11 sites across 1 country: China