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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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lenalidomide
Dexamethasone
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Relapsed, Refractory, Lenalidomide, Dexamethasone, open-label, CC-5013-MM-021

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who discontinued treatment but remained for long-term follow-up in the CC-5013-MM-021 study are required to sign an informed consent document (ICD) to roll over to the Safety Follow-up Phase of the Extended Access Program (EAP). These subjects do not require screening for eligibility but must agree to be followed for survival and Second Primary Malignancy (SPM) at a minimum of every 4 months (± 7 days) intervals for at least 5 years from the time the last on-study subject enrolled in Study CC-5013-MM-021.

Subjects who are consented for the Treatment Phase of the EAP must meet the following criteria to continue the same therapy as they received in the Study CC-5013-MM-021:

  1. Completed at least 1year of lenalidomide plus low-dose dexamethasone (Rd) treatment and remained progression free under Rd treatment in Study CC-5013-MM-021 at the time of screening visit of this EAP.
  2. Able to adhere study visit schedule, compliance with study drug and other protocol requirements in Study CC-5013-MM-024.
  3. Consented to the EAP protocol.
  4. Must agree to comply with all Pregnancy Prevention requirements.

  5. Females of childbearing potential (FCBP)1:

    • Must agree to use, and be able to comply with, at least 2 forms of reliable contraception simultaneously or to practice complete abstinence from heterosexual intercourse without interruption, from transferring/rolling over from the CC-5013-MM-021 study, at the screening visit for eligibility, throughout study drug therapy (including dose interruptions) and for 28 days after the end of study drug therapy, even if she has amenorrhea. This applies even if the subject practices complete and continued abstinence confirmed on a monthly basis.
    • Must agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 IU/mL (i.e., negative pregnancy test) at screening for eligibility and then every 28 days while on study. For any FCBP, pregnancy testing must continue at the same frequency as during the MM-021 study. If regular or no menstrual cycles, she must agree to ongoing pregnancy testing during the course of the study (every 28 days), during dose interruptions, at study discontinuation and 28 days following study drug discontinuation. If menstrual cycles are irregular, pregnancy testing must occur every 14 days while on study, at study discontinuation and at 14 and 28 days following study drug discontinuation. This requirement also applies to females of childbearing potential who practice complete and continued sexual abstinence.
    • Must agree not to breastfeed during study drug therapy and for at least 28 days following study drug discontinuation.

  6. Male subjects:

    • Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and at least 28 days following study drug discontinuation.
    • Must agree to not donate semen or sperm during study drug therapy and for at least 28 days following study drug discontinuation.

Subjects who have a positive finding of pregnancy testing at screening will not be eligible for the Treatment Phase of the EAP but will be consented for the Safety Follow-up Phase in the EAP.

Exclusion Criteria:

  • Subjects will not continue treatment at the discretion of the physician if any of the following criteria occurred during treatment in the CC-5013-MM-021 study or during the Screening Phase.

All subjects that are not eligible to continue treatment will enter the Safety Follow-up Phase:

  1. Serious hypersensitivity or anaphylaxis to lenalidomide or dexamethasone.
  2. Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
  3. Any other condition, including the presence of serious laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  4. Previously discontinued lenalidomide treatment due to toxicity.

  5. Newly diagnosed malignancy other than Multiple Myeloma (MM), except the following:

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) or prostate cancer that is curative

Sites / Locations

  • Peking University Third Hospital
  • Peking Union Medical College Hospital
  • The 301 Hospital-Chinese PLA General Hospital
  • Xiangya Hospital of Central South University
  • Guangdong General Hospital
  • Nanfang Hospital of Southern medicine university in Guangzhou
  • 1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )
  • 1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )
  • Shanghai Changzheng Hospital
  • Shanghai 6th Hospital
  • The 1st Hospital of Soochow University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide and dexamethasone

Arm Description

Cycle 1: 25 mg oral lenalidomide once daily on Days 1-21 every 28 Days and 40 mg oral dexamethasone on Days 8, 15, and 22. Cycle 2 and beyond: 25 oral lenalidomide once daily on Days 1-21 every 28 days and 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22. The starting doses of Rd regimen will be the same last doses that the subjects received in Study CC-5013-MM-021, unless event(s) that require dose adjustments (dose modifications, reductions and interruptions) per protocol occurred prior to roll-over.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 to Progression (TTP)
Time to progression is defined as the time between randomization and disease progression as determined by the investigator
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.

Full Information

First Posted
January 23, 2015
Last Updated
November 7, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02348528
Brief Title
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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2012 (Actual)
Primary Completion Date
September 29, 2016 (Actual)
Study Completion Date
September 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Relapsed, Refractory, Lenalidomide, Dexamethasone, open-label, CC-5013-MM-021

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide and dexamethasone
Arm Type
Experimental
Arm Description
Cycle 1: 25 mg oral lenalidomide once daily on Days 1-21 every 28 Days and 40 mg oral dexamethasone on Days 8, 15, and 22. Cycle 2 and beyond: 25 oral lenalidomide once daily on Days 1-21 every 28 days and 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22. The starting doses of Rd regimen will be the same last doses that the subjects received in Study CC-5013-MM-021, unless event(s) that require dose adjustments (dose modifications, reductions and interruptions) per protocol occurred prior to roll-over.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
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
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS
Description
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
Title
Time to Progression (TTP)
Description
Time to progression is defined as the time between randomization and disease progression as determined by the investigator
Time Frame
approximately 4 years
Title
Overall Survival (OS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who discontinued treatment but remained for long-term follow-up in the CC-5013-MM-021 study are required to sign an informed consent document (ICD) to roll over to the Safety Follow-up Phase of the Extended Access Program (EAP). These subjects do not require screening for eligibility but must agree to be followed for survival and Second Primary Malignancy (SPM) at a minimum of every 4 months (± 7 days) intervals for at least 5 years from the time the last on-study subject enrolled in Study CC-5013-MM-021. Subjects who are consented for the Treatment Phase of the EAP must meet the following criteria to continue the same therapy as they received in the Study CC-5013-MM-021: Completed at least 1year of lenalidomide plus low-dose dexamethasone (Rd) treatment and remained progression free under Rd treatment in Study CC-5013-MM-021 at the time of screening visit of this EAP. Able to adhere study visit schedule, compliance with study drug and other protocol requirements in Study CC-5013-MM-024. Consented to the EAP protocol. Must agree to comply with all Pregnancy Prevention requirements. Females of childbearing potential (FCBP)1: Must agree to use, and be able to comply with, at least 2 forms of reliable contraception simultaneously or to practice complete abstinence from heterosexual intercourse without interruption, from transferring/rolling over from the CC-5013-MM-021 study, at the screening visit for eligibility, throughout study drug therapy (including dose interruptions) and for 28 days after the end of study drug therapy, even if she has amenorrhea. This applies even if the subject practices complete and continued abstinence confirmed on a monthly basis. Must agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 IU/mL (i.e., negative pregnancy test) at screening for eligibility and then every 28 days while on study. For any FCBP, pregnancy testing must continue at the same frequency as during the MM-021 study. If regular or no menstrual cycles, she must agree to ongoing pregnancy testing during the course of the study (every 28 days), during dose interruptions, at study discontinuation and 28 days following study drug discontinuation. If menstrual cycles are irregular, pregnancy testing must occur every 14 days while on study, at study discontinuation and at 14 and 28 days following study drug discontinuation. This requirement also applies to females of childbearing potential who practice complete and continued sexual abstinence. Must agree not to breastfeed during study drug therapy and for at least 28 days following study drug discontinuation. Male subjects: Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and at least 28 days following study drug discontinuation. Must agree to not donate semen or sperm during study drug therapy and for at least 28 days following study drug discontinuation. Subjects who have a positive finding of pregnancy testing at screening will not be eligible for the Treatment Phase of the EAP but will be consented for the Safety Follow-up Phase in the EAP. Exclusion Criteria: Subjects will not continue treatment at the discretion of the physician if any of the following criteria occurred during treatment in the CC-5013-MM-021 study or during the Screening Phase. All subjects that are not eligible to continue treatment will enter the Safety Follow-up Phase: Serious hypersensitivity or anaphylaxis to lenalidomide or dexamethasone. Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document. Any other condition, including the presence of serious laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. Previously discontinued lenalidomide treatment due to toxicity. Newly diagnosed malignancy other than Multiple Myeloma (MM), except the following: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) or prostate cancer that is curative
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jacques, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100081
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The 301 Hospital-Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
300200
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital of Southern medicine university in Guangzhou
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Shanghai 6th Hospital
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
The 1st Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China

12. IPD Sharing Statement

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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

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