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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02719613




Registration number
NCT02719613
Ethics application status
Date submitted
16/03/2016
Date registered
25/03/2016
Date last updated
26/07/2024

Titles & IDs
Public title
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab
Scientific title
Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab
Secondary ID [1] 0 0
2016-000037-51
Secondary ID [2] 0 0
CA204-185
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Nivolumab

Experimental: Elotuzumab - This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol.


Treatment: Drugs: Elotuzumab
Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.

Treatment: Drugs: Dexamethasone
Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study.

Treatment: Drugs: Dexamethasone
Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.

Treatment: Drugs: Lenalidomide
Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.

Treatment: Drugs: Bortezomib
Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study.

Treatment: Drugs: Pomalidomide
Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.

Treatment: Drugs: Nivolumab
Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.
Timepoint [1] 0 0
Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
Secondary outcome [1] 0 0
All serious adverse events (SAEs) will be collected.
Timepoint [1] 0 0
Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
Secondary outcome [2] 0 0
All Grade 5 adverse events (AEs) will be collected.
Timepoint [2] 0 0
Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
Secondary outcome [3] 0 0
All adverse events (AEs) previously not reported will be collected.
Timepoint [3] 0 0
Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
Secondary outcome [4] 0 0
All adverse events (AEs) leading to discontinuation will be collected.
Timepoint [4] 0 0
Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com



* Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol
* Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
* Males and Females, ages 18 and older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* All participants previously discontinued from an elotuzumab study for any reason
* Participants not receiving clinical benefit from previous study therapy
* Participants who are not medically well enough to receive study therapy as determined by the investigator

Other protocol defined inclusion/exclusion criteria could apply

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2024
Actual
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 0034 - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Belgium
State/province [12] 0 0
Antwerpen
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Halifax
Country [15] 0 0
Greece
State/province [15] 0 0
Athens
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Italy
State/province [17] 0 0
Ancona
Country [18] 0 0
Italy
State/province [18] 0 0
Firenze
Country [19] 0 0
Italy
State/province [19] 0 0
Genova
Country [20] 0 0
Italy
State/province [20] 0 0
Ravenna
Country [21] 0 0
Italy
State/province [21] 0 0
Terni
Country [22] 0 0
Italy
State/province [22] 0 0
Torino
Country [23] 0 0
Japan
State/province [23] 0 0
Aomori
Country [24] 0 0
Japan
State/province [24] 0 0
Gunma
Country [25] 0 0
Japan
State/province [25] 0 0
Osaka
Country [26] 0 0
Japan
State/province [26] 0 0
Tokyo
Country [27] 0 0
Japan
State/province [27] 0 0
Chiba
Country [28] 0 0
Japan
State/province [28] 0 0
Kasama-shi
Country [29] 0 0
Poland
State/province [29] 0 0
Chorzow
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Romania
State/province [31] 0 0
Bucuresti
Country [32] 0 0
Romania
State/province [32] 0 0
Iasi
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Toledo
Country [35] 0 0
Turkey
State/province [35] 0 0
Cebeci Ankara
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.
Trial website
https://clinicaltrials.gov/study/NCT02719613
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02719613