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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Peking University Third Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The 301 Hospital-Chinese PLA General Hospital
Beijing, China
Adverse Events (AEs)
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A diagnosis or syndrome should be recorded on the AE page of the electronic case report form (eCRF) rather than the individual signs or symptoms of the diagnosis or syndrome. An overdose, accidental or intentional, whether or not it is associated with an AE, or abuse, withdrawal, sensitivity or toxicity to an investigational product should be reported as an AE. If an overdose is associated with an AE, the overdose and adverse event should be reported as separate terms.
Time frame: approximately 4 years
Progression Free Survival (PFS
Progression Free Survival is defined as the time between randomization and the first documented progressive disease or death, whichever occurred first
Time frame: approximately 4 years
Time to Progression (TTP)
Time to progression is defined as the time between randomization and disease progression as determined by the investigator
Time frame: approximately 4 years
Overall Survival (OS)
Overall Survival is defined as the time between randomization and death Safety Issue: No Click here to enter additional Secondary Outcome Measures following the format above.
Time frame: approximately 4 years
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Xiangya Hospital of Central South University
Changsha, China
Guangdong General Hospital
Guangzhou, China
Nanfang Hospital of Southern medicine university in Guangzhou
Guangzhou, China
1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )
Hangzhou, China
1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )
Hangzhou, China
Shanghai Changzheng Hospital
Shanghai, China
Shanghai 6th Hospital
Shanghai, China
...and 1 more locations