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NCT02719613 Clinical Trial

Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab

Multiple Myeloma Clinical Trial

Official title:
Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02719613
Other study ID # CA204-185
Secondary ID 2016-000037-51
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 15, 2016
Est. completion date June 28, 2024

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 67
Est. completion date June 28, 2024
Est. primary completion date June 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 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

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations
Country Name City State
Australia Local Institution Heidelberg Victoria
Belgium Local Institution Antwerpen
Canada Cross Cancer Institute Edmonton Alberta
Canada Local Institution Halifax
Canada Local Institution - 0011 Toronto Ontario
Greece Local Institution Athens
Hungary Local Institution - 0036 Budapest
Italy Local Institution Ancona
Italy Local Institution Firenze
Italy Local Institution Genova
Italy Local Institution Torino
Japan Local Institution - 0046 Aomori-shi Aomori
Japan Local Institution - 0050 Chiba
Japan Local Institution Kasama-shi
Japan Local Institution Koto-ku Tokyo
Japan Local Institution Osaka-shi Osaka
Japan Local Institution Shibukawa-shi Gunma
Poland Local Institution Chorzow
Poland Local Institution - 0026 Warszawa
Poland Local Institution - 0039 Warszawa
Romania Local Institution Bucuresti
Romania Local Institution - 0029 Iasi
Spain Local Institution - 0040 Salamanca
Spain Local Institution Toledo
Turkey Local Institution - 0031 Cebeci Ankara
United Kingdom Local Institution London
United States Emory University Atlanta Georgia
United States Comprehensive Blood And Cancer Center Bakersfield California
United States St. Luke's University Health Network Bethlehem Pennsylvania
United States Dana-Farber Cancer Institute Boston Massachusetts
United States University Of Chicago Medical Center Chicago Illinois
United States Texas Oncology Dallas Texas
United States Rocky Mountain Cancer Centers (Williams) - USOR Denver Colorado
United States Robert A. Moss, Md Facp, Inc. Fountain Valley California
United States Investigative Clinical Research Of Indiana, Llc Indianapolis Indiana
United States Local Institution - 0021 Jacksonville Florida
United States Icahn School Of Medicine At Mount Sinai New York New York
United States Local Institution - 0008 Saint Louis Missouri
United States Florida Cancer Specialists - North Saint Petersburg Florida
United States Local Institution - 0020 Tucson Arizona
United States Local Institution - 0016 West Hollywood California

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Greece,  Hungary,  Italy,  Japan,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 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 All serious adverse events (SAEs) will be collected. 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 All Grade 5 adverse events (AEs) will be collected. 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 All adverse events (AEs) previously not reported will be collected. 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 All adverse events (AEs) leading to discontinuation will be collected. 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.
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
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